Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171776
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-11-29
Brief Title:
Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions Using Three Different Lining Materials-a Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
The goal of this clinical trial is to compare postoperative pain of calcium silicate cement and resin-based tricalcium silicate TheraCal LC versus chemically Cured Glass Ionomer cement FujiXI in conservative management of very deep carious lesions by selective caries removal
Detailed Description:
p-Patients having Permanent posterior teeth with very deep carious lesions I 1 calcium silicate cement I 2 resin-based tricalcium silicate TheraCal LC C- chemically Glass Ionomer cement O- Outcome name Measuring Device Measuring Unit Primary1ry postoperative pain 1- Refrigerant spray endo frost 2- Percussion Marchi et al 2006 3- Palpation Binary Secondry2ry Peri-apical pathosis Digital radiograph Hashem et al 2015 Binary
T- one month three months six months12 months24 months evaluation S-Randomized clinical trial 7- Trial design Randomized Controlled Trial Trial type single blind parallel arms design Trial framework Equivalence frame Allocation ratio 11 Research question In patients having permanent posterior teeth with very deep carious lesions will calcium silicate cement or resin-based tricalcium silicate TheraCal LC in comparison to chemically cured glass ionomer cement result in clinical and radiographical success Methods Participants interventions and outcomes 8-Study Settings This clinical trial will be held in the Faculty of Oral Dental Medicine Cairo University Egypt
9- Eligibility criteria
1 Eligibility Criteria of participants
Inclusion Criteria of participants
1 Patients male or female older than 18 y in good general health
2 A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical PA radiograph Clinically according to International Caries Detection and Assessment System ICDAS II score 4
3 Clinical symptoms of reversible pulpitis
4 Positive pulp response to electric pulp test or thermal stimulation
5 No PA changes viewed on PA radiograph
Exclusion Criteria of participants
1 Clinical symptoms of irreversible pulpitis requiring endodontic treatment
2 Presence of fistulas or swelling
3 Mobile teeth or tenderness to percussion
4 Anterior teeth with aesthetic concerns
5 Pregnant women in view of requirements for radiographs
6 Patients younger than 18 y
7 Patients unable to give consent
2 Exclusion criteria of the teeth
Teeth with symptoms of irreversible pulpitis including persistent dull throbbing pain sharp spontaneous pain or pain exacerbated by lying down will be excluded In addition patients will be withdrawn from the study if pulp exposure occurred during the baseline operative intervention
3 Assessor and Operator criteria
Operator OM PHD Assessor AR PHD 10a- Interventions Pre-operative clinical assessment
1 Thermal testing using Refrigerant spray Endo Frost Roeko Langenau Germany
2 percussion test
3 Palpation and clinical examination for the signs of inflammation pain abscess sinus tract and mobility
4 PA radiographs using digital radiograph will be taken at baseline T0 and will be assessed to exclude any signs of irreversible pulpitis widening of periodontal ligament PDL or PA lesions
These tests were carried out at baseline pre-operatively and at 1 month 3 612 and 24-month in post-operative follow-up visits
Caries removal procedure
Local anesthesia will be given to the patient then complete isolation to the tooth using rubber dame the operator OM will open the enamel if needed using high speed hand piece NSK NSK America CorpUSA with high speed diamond round bur Standard shank Ø16mm x 19mm FG Diamond medium grit komet Rock Hill SC United States under copious irrigation Then in caries removal from the walls carbon-steel rose-head bur komet Rock Hill SC United States in low speed hand piece WH DentalwerkBürmoos GmbH Bürmoos AustriaFinally the deeper caries will be removed using spoon excavator no 49 61 or 73 DentsplyMaillefer leaving the last layer affected dentine without any direct pulp exposure Clarkson et al 2021 Intervention RetroMTA BioMTA Seoul Korea and TheraCal LC Bisco Inc Schaumburg IL USA The material will be applied according to manufacturer instructions
Comparator GC Fuji IX GP GC America Inc Alsip ILUSA The material will be applied according to manufacturer instructions Final restoration application Filtek Z250 Universal Restorative 3M Canada London Ontario Canada
Adhesive system
Scotchbond Universal Etchant 3M ESPE St Paul MN USA Single Bond Universal adhesive 3M ESPE St Paul MN USA
The material will be applied according to manufacturer instruction as follows Etchant will be applied for 15 seconds then rinsed for 15 seconds then cavity will be dried using gentle air stream Adhesive material will be applied to the cavity and rubbed for 20 second then will be air thinned using gentle air for 5 seconds and photo-cured for 20 seconds using LED light curing unit After applying the adhesive composite will be applied then photo-cured for 40 seconds using LED light curing unit
11b-Restoration will be removed when there are any signs of leakage fracture or sever postoperative pain due to pulpal response and will unergo endodontic treatment
13- Radiographical assessment digital periapical radiograph FONA XDC FONA SRL Assago Italy will be tacken by AR at T0 after the operative procedure and after 1 monthT1 3 T3 6 T6 12 T12 and 24 T24 months using paralleling technique to standardize the final record for each patient then processed in DIGORA optime sordexTuusula Finland
11- Outcomes outcomes criteria measuring devices scores characteristics measuring unite Criterion M device Score Characteristics M unit
13- Recruitment Patients will be recruited byAR from clinic of conservative dentistry department in Faculty of Oral Dental Medicine Cairo University where there is a continuous and high patient flow from which eligible patients will be recruited to fulfill the eligibility criteria 1 week before intervention
Methods Assignment of interventions
Allocation
15a- Sequence generation Simple randomization will be done by generating numbers from 199 using Random Sequence Generator Randomness and Integrity Services Ltd httpswwwrandomorg
No from 1-33 represents the first intervention and from 34-66 is second intervention and from 67-99 is the comparator
15b- Allocation concealment Operator OM will choose between numbers in an opaque sealed envelope which will be arranged by AR who will not be involved in any of the phases of the clinical trial The side to which intervention or control is assigned will be recorded on a computer by OM and all records of all patients will be kept with AR 16- Blinding The operator will not be blinded to material assignment because of the difference in the application protocol of the restorative materials which prohibited blinding of the operator however assessors will be blinded to the material assignment
Methods Data collection management and analysis 17a- Data collection methods
Baseline data collection
For every patient medical and dental history will be taken Examination charts will be filled by AR
T- one month three months six months12 months24 months evaluation S-Randomized clinical trial 7- Trial design Randomized Controlled Trial Trial type single blind parallel arms design Trial framework Equivalence frame Allocation ratio 11 Research question In patients having permanent posterior teeth with very deep carious lesions will calcium silicate cement or resin-based tricalcium silicate TheraCal LC in comparison to chemically cured glass ionomer cement result in clinical and radiographical success Methods Participants interventions and outcomes 8-Study Settings This clinical trial will be held in the Faculty of Oral Dental Medicine Cairo University Egypt
9- Eligibility criteria
1 Eligibility Criteria of participants
Inclusion Criteria of participants
1 Patients male or female older than 18 y in good general health
2 A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical PA radiograph Clinically according to International Caries Detection and Assessment System ICDAS II score 4
3 Clinical symptoms of reversible pulpitis
4 Positive pulp response to electric pulp test or thermal stimulation
5 No PA changes viewed on PA radiograph
Exclusion Criteria of participants
1 Clinical symptoms of irreversible pulpitis requiring endodontic treatment
2 Presence of fistulas or swelling
3 Mobile teeth or tenderness to percussion
4 Anterior teeth with aesthetic concerns
5 Pregnant women in view of requirements for radiographs
6 Patients younger than 18 y
7 Patients unable to give consent
2 Exclusion criteria of the teeth
Teeth with symptoms of irreversible pulpitis including persistent dull throbbing pain sharp spontaneous pain or pain exacerbated by lying down will be excluded In addition patients will be withdrawn from the study if pulp exposure occurred during the baseline operative intervention
3 Assessor and Operator criteria
Operator OM PHD Assessor AR PHD 10a- Interventions Pre-operative clinical assessment
1 Thermal testing using Refrigerant spray Endo Frost Roeko Langenau Germany
2 percussion test
3 Palpation and clinical examination for the signs of inflammation pain abscess sinus tract and mobility
4 PA radiographs using digital radiograph will be taken at baseline T0 and will be assessed to exclude any signs of irreversible pulpitis widening of periodontal ligament PDL or PA lesions
These tests were carried out at baseline pre-operatively and at 1 month 3 612 and 24-month in post-operative follow-up visits
Caries removal procedure
Local anesthesia will be given to the patient then complete isolation to the tooth using rubber dame the operator OM will open the enamel if needed using high speed hand piece NSK NSK America CorpUSA with high speed diamond round bur Standard shank Ø16mm x 19mm FG Diamond medium grit komet Rock Hill SC United States under copious irrigation Then in caries removal from the walls carbon-steel rose-head bur komet Rock Hill SC United States in low speed hand piece WH DentalwerkBürmoos GmbH Bürmoos AustriaFinally the deeper caries will be removed using spoon excavator no 49 61 or 73 DentsplyMaillefer leaving the last layer affected dentine without any direct pulp exposure Clarkson et al 2021 Intervention RetroMTA BioMTA Seoul Korea and TheraCal LC Bisco Inc Schaumburg IL USA The material will be applied according to manufacturer instructions
Comparator GC Fuji IX GP GC America Inc Alsip ILUSA The material will be applied according to manufacturer instructions Final restoration application Filtek Z250 Universal Restorative 3M Canada London Ontario Canada
Adhesive system
Scotchbond Universal Etchant 3M ESPE St Paul MN USA Single Bond Universal adhesive 3M ESPE St Paul MN USA
The material will be applied according to manufacturer instruction as follows Etchant will be applied for 15 seconds then rinsed for 15 seconds then cavity will be dried using gentle air stream Adhesive material will be applied to the cavity and rubbed for 20 second then will be air thinned using gentle air for 5 seconds and photo-cured for 20 seconds using LED light curing unit After applying the adhesive composite will be applied then photo-cured for 40 seconds using LED light curing unit
11b-Restoration will be removed when there are any signs of leakage fracture or sever postoperative pain due to pulpal response and will unergo endodontic treatment
13- Radiographical assessment digital periapical radiograph FONA XDC FONA SRL Assago Italy will be tacken by AR at T0 after the operative procedure and after 1 monthT1 3 T3 6 T6 12 T12 and 24 T24 months using paralleling technique to standardize the final record for each patient then processed in DIGORA optime sordexTuusula Finland
11- Outcomes outcomes criteria measuring devices scores characteristics measuring unite Criterion M device Score Characteristics M unit
13- Recruitment Patients will be recruited byAR from clinic of conservative dentistry department in Faculty of Oral Dental Medicine Cairo University where there is a continuous and high patient flow from which eligible patients will be recruited to fulfill the eligibility criteria 1 week before intervention
Methods Assignment of interventions
Allocation
15a- Sequence generation Simple randomization will be done by generating numbers from 199 using Random Sequence Generator Randomness and Integrity Services Ltd httpswwwrandomorg
No from 1-33 represents the first intervention and from 34-66 is second intervention and from 67-99 is the comparator
15b- Allocation concealment Operator OM will choose between numbers in an opaque sealed envelope which will be arranged by AR who will not be involved in any of the phases of the clinical trial The side to which intervention or control is assigned will be recorded on a computer by OM and all records of all patients will be kept with AR 16- Blinding The operator will not be blinded to material assignment because of the difference in the application protocol of the restorative materials which prohibited blinding of the operator however assessors will be blinded to the material assignment
Methods Data collection management and analysis 17a- Data collection methods
Baseline data collection
For every patient medical and dental history will be taken Examination charts will be filled by AR
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?:
False
Is an FDA AA801 Violation?:
None