Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04888676
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2021-05-06
Brief Title:
Clinical Evaluation of Self- Adhesive Bulk-fill Resin Composite Versus Conventionally Bonded Bulk-fill Resin Composite in Restoration of Proximal Lesions
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Clinical Evaluation of Self- Adhesive Bulk-fill Resin Composite Versus Conventionally Bonded Bulk-fill Resin Composite in Restoration of Proximal Lesions Over a Period of 18 Months Follow-up A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to evaluate and compare the clinical performance of Self- Adhesive Bulk fill Resin Composite Versus Conventionally Bonded Bulk fill resin composite in Restoration of Proximal Lesions Over a Period of 18 months Follow-up
Examination and selection of all patients will be done according to inclusion and exclusion criteriaA Class II cavity will be prepared after local anesthesia has been given as required Sectional matricing and wedging will be done Followed by placement of restorative material according to the randomization sequence For the intervention The sectional matrix will be applied first followed by filling of cavity with Advanced Self- Adhesive bulk-fill Resin Composite Surefil one Dentsupply Sirona in increments of 3-4mmFor the control group
The sectional matrix will be applied first followed by filling of cavity with bulk-fill resin composite material GrandioSO x-tra bulk in increments of 3-4mmClinical evaluation will be done using using USPHS criteria at 612 and 18 months follow up
Examination and selection of all patients will be done according to inclusion and exclusion criteriaA Class II cavity will be prepared after local anesthesia has been given as required Sectional matricing and wedging will be done Followed by placement of restorative material according to the randomization sequence For the intervention The sectional matrix will be applied first followed by filling of cavity with Advanced Self- Adhesive bulk-fill Resin Composite Surefil one Dentsupply Sirona in increments of 3-4mmFor the control group
The sectional matrix will be applied first followed by filling of cavity with bulk-fill resin composite material GrandioSO x-tra bulk in increments of 3-4mmClinical evaluation will be done using using USPHS criteria at 612 and 18 months follow up
Detailed Description:
A Participants interventions outcomes 9 Study setting Study will be conducted in the Conservative Dentistry Department Faculty of Dentistry - Cairo University
10 Eligibility criteria 10a1 Inclusion criteria
Patient-related criteria
Patients consulting in one of the outpatient clinics listed above
Able to tolerate necessary restorative procedures
Provide informed consent
Accepts the 18 months follow-up period
Tooth related criteria
Teeth with primary proximal carious lesions
Teeth are vital according to pulp-sensitivity tests 10a2 Exclusion criteria
Patient-related criteria
Medically compromised patients as they will not be able to attend multiple appointments or may require special management
Pregnant women as radiographs cannot be taken for them
Allergy to any of the restorative materials including anesthetics
Uncooperative patients will not abide by the instructions or attend the appointments
Tooth related criteria
Deciduous teeth as the study is targeting only permanent teeth
Teeth with previous restorations which may add another variable to the study type of old restorative material extent of recurrent caries
Spontaneous pain or prolonged pain after sensitivity tests cold and electrical tests which would indicate irreversible pulpal damage
Negative sensitivity tests periapical radiolucencies and sensitivity to axial or lateral percussion which would indicate pulp necrosis
Teeth presenting external or internal resorption with adverse pulpal reactions which may affect the outcome of the study
Teeth with cervical caries which cant be evaluated on periapical radiographs 11 Interventions 11a Examination and diagnosis Examination and selection of all patients will be done according to inclusion and exclusion criteria Diagnosis of patients chief complaint and teeth that will be involved in this study will be done Teeth are to be chosen according to standardized radiographic examination Teeth should have proximal primary carious lesions
11b Cavity preparation procedure A Class II cavity will be prepared after local anesthesia has been given as required The cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond burs of different sizes Sharp excavators will allow accessible removal of soft carious lesions will be used Any tooth that will suffer from pulpal exposure will be excluded from the study Finishing of the cavity walls will be done using a fine-grit yellow coded diamond bur
11c Isolation Rubber dam isolation will be done 11d Matricing and wedging Sectional matricing and wedging will be done Followed by placement of restorative material according to the randomization sequence
11e For the intervention The sectional matrix will be applied first followed by filling of cavity with Advanced Self- Adhesive bulk-fill Resin Composite Surefil one Dentsupply Sirona in increments of 3-4mm as required to end up with leaving an occlusal space on top of at least 2mm Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs Polishing will be done using pre-impregnated rubber cups Materials will be manipulated according to manufacturer instructions
11f For the control group The sectional matrix will be applied first followed by filling of cavity with bulk-fill resin composite material GrandioSO x-tra bulk in increments of 3-4mm as required to end up with leaving an occlusal space on top of at least 2mm Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs Polishing will be done using pre-impregnated rubber cups Materials will be manipulated according to manufacturer instructions
11g Intervention modification Restoration will be removed when there are any signs of leakage fracture or severe post-operative pain due to pulpal response
11h Intervention adherence The patients understanding of their conditions and treatments and the amount of information given to the patient is positively related to adherence to the study and instructions given Thus the operator MS will inform the participants about all steps from the beginning to the end and explain the importance of restoring their teeth with such esthetic restorative materials following instructions attending follow up visits and how to maintain good oral hygiene This will be done using simple oral conversation emphasized by written and illustrated material whenever possible Oral hygiene of the participants will be enhanced before intervention and any other chief and subsidiary complaint will be managed in order to modify their behavior
12 Outcomes Clinical evaluation using USPHS criteria 14 Sample Size We are planning a study of independent cases and controls Sample size was calculated based on the previous study by Guney et al in 2020 Prior data indicated that the probability of score A for marginal adaptation for bulk fill composite was 0861 and score B was 0139 with effect size w 0722 n16 If the estimated probability of score A for marginal adaptation for self adhesive restorative material is 085 and score B is 015 with effect size w 07 n17 we will need to study a total of 33 restorations to be able to reject the null hypothesis that the success rates for case and controls are equal with probability power 08 This was increased to 40 subjects 20 in each group to compensate for losses during follow up The type I error probability associated with this test of this null hypothesis is 005 Sample size was calculated using GPower version 3192 for windows using chi-square test 15 Recruitment Patients will be recruited by the principle investigator MS from outpatient clinic of conservative dentistry department in Faculty of Dentistry Cairo University from which eligible patients will be recruited to fulfill the eligibility criteria according to participant timeline
B Assignment of interventions 16 Allocation - sequence generation 16a Random sequence generation Randomization Simple randomization will be assigned for participants by generating numbers from 148 using Random Sequence Generator Randomness and Integrity Services Ltd httpswwwrandomorg by DK Each generated random number will represent assigning both intervention and comparator to each patient in a random manner
16b Allocation concealment mechanism The restorative technique will be selected according to randomized numbers in a sealed envelope
16c Implementation Randomization will be performed by DK 17 Blinding Double Blinded The participants Participants will be blinded to the technique used since the patient will attend the same number of visits and he can not differentiate between different restorative materials
Blinding of the operator The operator cannot be blinded because of the use of different restorative materials applied in each group
The outcome assessor The outcome assessor will be blinded to the material used This will be performed by MA and YH Therefore it is necessary that the assessors wont be included in the preclinical assessment
C Data collection management and analysis 18 Data collection methods 18a Data collection methods 18ai Baseline data collection For every patient medical and dental history will be taken Examination charts will be filled by MS
18aii Outcome data collection Modified USPHS criteria for dental restoration will be evaluated by two assessors MA YH at baseline after 6 12 and 18 months if both assessors differ in score they will discuss the outcome if they did not agree a third assessor DM will resolve the conflict To achieve inter-examiners reliability at the beginning of the study the assessors will perform a profound assessment training program by performing repeated assessments of 36 proximal surface restorations using modified USHPS criteria The main supervisor OS will supervise the training program to ensure that the assessors MA YH will be calibrated before starting their evaluation
18b Patient retention A record of patients phone number will be included in every patients chart Phone call will be diverted to each patient in order to remind himher for the time of hisher visit MS If the patient did not reply for any reason another visit will be scheduled within a week
19 Data management Data entry will be carried out by MS and revised by DM All data will be stored on computer and will be encrypted using a password This will be done to allow accurate data entry through revision and protect data from being incorrectly used Data will be backed up on another storage device to prevent it from being lost
20 Statistical methods Data will be analyzed using IBM SPSS advanced statistics Statistical Package for Social Sciences version 25 SPSS Inc Chicago ILCategorical data will be described as absolute risk for each intervention independently and relative risk when comparing both interventions Comparisons between categorical variables will be performed using the chi square test A p-value less than or equal to 005 will be considered statistically significant and all tests will be two tailed Statistical power of the study will be set at 80 with 95 confidence level
D Data monitoring
21 Monitoring The main supervisor OS will monitor this study Her role is to monitor any risk of bias could be done from participants operator or assessors Also to monitor blinding of the assessors and patient safety outstanding benefits or harms
22 Harms The principle investigator MS should inform participants about the possible harms pain loss of restoration leakage and fracture of restorations if present Participants are allowed to contact the operator at moment through telephone For assessment radiograph inspection percussion and sensitivity tests will be performed The data will be reported to the co-supervisor DM and managed through removal of restoration alleviation of pain and replacement with control restoration
23 Auditing In the present trial auditing will be done by the main supervisors and co-supervisors OS and DM to assure quality of the research methods restorative technique and interventions
Section IV
Ethics and dissemination 24 Research ethics approval Application forms for carrying out the clinical trial checklist and informed consent of Research Ethics Committee REC Faculty of Dentistry Cairo University will be retrieved and filled then will be delivered for REC committee for approval this is done to prevent any ethical problems during the study or any harm for any of the participants
25 Protocol amendments If a new protocol will be used a protocol amendment will be submitted containing a new copy of the new protocol and brief explanation about the differences between it and the previous protocols If there is a change in the existing protocol that affects safety of subjects investigation scope or scientific quality of the trial an amendment containing a brief explanation about the change will be submitted If a new author will be added to accomplish the study an amendment including the investigators data and qualifications to conduct the investigation will be submitted to prevent ghost authorship
26 Consent Researcher MS will introduce the trial to patients and provide full explanation of its aim and benefits in plain language Patients will then be able to have an informed discussion with the researcher Researcher will obtain written consent from patients willing to participate in the trial All consent forms have been translated into Arabic
27 Confidentiality Name and personal data of the participants will not appear on the protocol form and will be maintained secured for 10 years after the trial This is done for protection of participants privacy and civil rights
28 Declaration of interests There is no conflict of interest no funding or material supplying from any parties
29 Access to data Access to final data will be allowed to the operator MS and main and co- supervisors OS and DM of the study who are not involved in assessment of the outcome
30 Ancillary and post-trial care Patients will be followed up after restoration to ensure oral hygiene measures When there is any evidence of restoration failure patients will be treated by immediate restoration removal and control restoration placement
31 Dissemination policy
Full protocol will be published online in Clinicaltrialsgov to avoid repetition and keep the integrity of the research work
Thesis will be discussed and defended in front of a judgment committee
The study will be published to report the results of this clinical trial
10 Eligibility criteria 10a1 Inclusion criteria
Patient-related criteria
Patients consulting in one of the outpatient clinics listed above
Able to tolerate necessary restorative procedures
Provide informed consent
Accepts the 18 months follow-up period
Tooth related criteria
Teeth with primary proximal carious lesions
Teeth are vital according to pulp-sensitivity tests 10a2 Exclusion criteria
Patient-related criteria
Medically compromised patients as they will not be able to attend multiple appointments or may require special management
Pregnant women as radiographs cannot be taken for them
Allergy to any of the restorative materials including anesthetics
Uncooperative patients will not abide by the instructions or attend the appointments
Tooth related criteria
Deciduous teeth as the study is targeting only permanent teeth
Teeth with previous restorations which may add another variable to the study type of old restorative material extent of recurrent caries
Spontaneous pain or prolonged pain after sensitivity tests cold and electrical tests which would indicate irreversible pulpal damage
Negative sensitivity tests periapical radiolucencies and sensitivity to axial or lateral percussion which would indicate pulp necrosis
Teeth presenting external or internal resorption with adverse pulpal reactions which may affect the outcome of the study
Teeth with cervical caries which cant be evaluated on periapical radiographs 11 Interventions 11a Examination and diagnosis Examination and selection of all patients will be done according to inclusion and exclusion criteria Diagnosis of patients chief complaint and teeth that will be involved in this study will be done Teeth are to be chosen according to standardized radiographic examination Teeth should have proximal primary carious lesions
11b Cavity preparation procedure A Class II cavity will be prepared after local anesthesia has been given as required The cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond burs of different sizes Sharp excavators will allow accessible removal of soft carious lesions will be used Any tooth that will suffer from pulpal exposure will be excluded from the study Finishing of the cavity walls will be done using a fine-grit yellow coded diamond bur
11c Isolation Rubber dam isolation will be done 11d Matricing and wedging Sectional matricing and wedging will be done Followed by placement of restorative material according to the randomization sequence
11e For the intervention The sectional matrix will be applied first followed by filling of cavity with Advanced Self- Adhesive bulk-fill Resin Composite Surefil one Dentsupply Sirona in increments of 3-4mm as required to end up with leaving an occlusal space on top of at least 2mm Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs Polishing will be done using pre-impregnated rubber cups Materials will be manipulated according to manufacturer instructions
11f For the control group The sectional matrix will be applied first followed by filling of cavity with bulk-fill resin composite material GrandioSO x-tra bulk in increments of 3-4mm as required to end up with leaving an occlusal space on top of at least 2mm Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs Polishing will be done using pre-impregnated rubber cups Materials will be manipulated according to manufacturer instructions
11g Intervention modification Restoration will be removed when there are any signs of leakage fracture or severe post-operative pain due to pulpal response
11h Intervention adherence The patients understanding of their conditions and treatments and the amount of information given to the patient is positively related to adherence to the study and instructions given Thus the operator MS will inform the participants about all steps from the beginning to the end and explain the importance of restoring their teeth with such esthetic restorative materials following instructions attending follow up visits and how to maintain good oral hygiene This will be done using simple oral conversation emphasized by written and illustrated material whenever possible Oral hygiene of the participants will be enhanced before intervention and any other chief and subsidiary complaint will be managed in order to modify their behavior
12 Outcomes Clinical evaluation using USPHS criteria 14 Sample Size We are planning a study of independent cases and controls Sample size was calculated based on the previous study by Guney et al in 2020 Prior data indicated that the probability of score A for marginal adaptation for bulk fill composite was 0861 and score B was 0139 with effect size w 0722 n16 If the estimated probability of score A for marginal adaptation for self adhesive restorative material is 085 and score B is 015 with effect size w 07 n17 we will need to study a total of 33 restorations to be able to reject the null hypothesis that the success rates for case and controls are equal with probability power 08 This was increased to 40 subjects 20 in each group to compensate for losses during follow up The type I error probability associated with this test of this null hypothesis is 005 Sample size was calculated using GPower version 3192 for windows using chi-square test 15 Recruitment Patients will be recruited by the principle investigator MS from outpatient clinic of conservative dentistry department in Faculty of Dentistry Cairo University from which eligible patients will be recruited to fulfill the eligibility criteria according to participant timeline
B Assignment of interventions 16 Allocation - sequence generation 16a Random sequence generation Randomization Simple randomization will be assigned for participants by generating numbers from 148 using Random Sequence Generator Randomness and Integrity Services Ltd httpswwwrandomorg by DK Each generated random number will represent assigning both intervention and comparator to each patient in a random manner
16b Allocation concealment mechanism The restorative technique will be selected according to randomized numbers in a sealed envelope
16c Implementation Randomization will be performed by DK 17 Blinding Double Blinded The participants Participants will be blinded to the technique used since the patient will attend the same number of visits and he can not differentiate between different restorative materials
Blinding of the operator The operator cannot be blinded because of the use of different restorative materials applied in each group
The outcome assessor The outcome assessor will be blinded to the material used This will be performed by MA and YH Therefore it is necessary that the assessors wont be included in the preclinical assessment
C Data collection management and analysis 18 Data collection methods 18a Data collection methods 18ai Baseline data collection For every patient medical and dental history will be taken Examination charts will be filled by MS
18aii Outcome data collection Modified USPHS criteria for dental restoration will be evaluated by two assessors MA YH at baseline after 6 12 and 18 months if both assessors differ in score they will discuss the outcome if they did not agree a third assessor DM will resolve the conflict To achieve inter-examiners reliability at the beginning of the study the assessors will perform a profound assessment training program by performing repeated assessments of 36 proximal surface restorations using modified USHPS criteria The main supervisor OS will supervise the training program to ensure that the assessors MA YH will be calibrated before starting their evaluation
18b Patient retention A record of patients phone number will be included in every patients chart Phone call will be diverted to each patient in order to remind himher for the time of hisher visit MS If the patient did not reply for any reason another visit will be scheduled within a week
19 Data management Data entry will be carried out by MS and revised by DM All data will be stored on computer and will be encrypted using a password This will be done to allow accurate data entry through revision and protect data from being incorrectly used Data will be backed up on another storage device to prevent it from being lost
20 Statistical methods Data will be analyzed using IBM SPSS advanced statistics Statistical Package for Social Sciences version 25 SPSS Inc Chicago ILCategorical data will be described as absolute risk for each intervention independently and relative risk when comparing both interventions Comparisons between categorical variables will be performed using the chi square test A p-value less than or equal to 005 will be considered statistically significant and all tests will be two tailed Statistical power of the study will be set at 80 with 95 confidence level
D Data monitoring
21 Monitoring The main supervisor OS will monitor this study Her role is to monitor any risk of bias could be done from participants operator or assessors Also to monitor blinding of the assessors and patient safety outstanding benefits or harms
22 Harms The principle investigator MS should inform participants about the possible harms pain loss of restoration leakage and fracture of restorations if present Participants are allowed to contact the operator at moment through telephone For assessment radiograph inspection percussion and sensitivity tests will be performed The data will be reported to the co-supervisor DM and managed through removal of restoration alleviation of pain and replacement with control restoration
23 Auditing In the present trial auditing will be done by the main supervisors and co-supervisors OS and DM to assure quality of the research methods restorative technique and interventions
Section IV
Ethics and dissemination 24 Research ethics approval Application forms for carrying out the clinical trial checklist and informed consent of Research Ethics Committee REC Faculty of Dentistry Cairo University will be retrieved and filled then will be delivered for REC committee for approval this is done to prevent any ethical problems during the study or any harm for any of the participants
25 Protocol amendments If a new protocol will be used a protocol amendment will be submitted containing a new copy of the new protocol and brief explanation about the differences between it and the previous protocols If there is a change in the existing protocol that affects safety of subjects investigation scope or scientific quality of the trial an amendment containing a brief explanation about the change will be submitted If a new author will be added to accomplish the study an amendment including the investigators data and qualifications to conduct the investigation will be submitted to prevent ghost authorship
26 Consent Researcher MS will introduce the trial to patients and provide full explanation of its aim and benefits in plain language Patients will then be able to have an informed discussion with the researcher Researcher will obtain written consent from patients willing to participate in the trial All consent forms have been translated into Arabic
27 Confidentiality Name and personal data of the participants will not appear on the protocol form and will be maintained secured for 10 years after the trial This is done for protection of participants privacy and civil rights
28 Declaration of interests There is no conflict of interest no funding or material supplying from any parties
29 Access to data Access to final data will be allowed to the operator MS and main and co- supervisors OS and DM of the study who are not involved in assessment of the outcome
30 Ancillary and post-trial care Patients will be followed up after restoration to ensure oral hygiene measures When there is any evidence of restoration failure patients will be treated by immediate restoration removal and control restoration placement
31 Dissemination policy
Full protocol will be published online in Clinicaltrialsgov to avoid repetition and keep the integrity of the research work
Thesis will be discussed and defended in front of a judgment committee
The study will be published to report the results of this clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None