Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03908489
Status:
UNKNOWN
Last Update Posted:
2019-04-25
First Post:
2019-04-05
Brief Title:
Evaluation of Post-operative Pain After Vital Pulpotomy in Primary Molars Using Allium Sativum Oil Versus MTA
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation of Post-operative Pain After Vital Pulpotomy of Primary Molars Using Allium Sativum Oil Versus Mineral Trioxide Aggregate MTA A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
NOT_YET_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:
Preservation of the remaining vital portion of curiously exposed pulpal tissue in primary teeth was one of the most frequent problems in pediatric dentistry To solve this problem pulpotomy therapy was introduced Pulpotomy involves amputation of the coronal portion of affected or infected dental pulp treatment of the remaining vital radicular pulp tissue surface should preserve the vitality and function of all or part of the remaining radicular portion of the pulp Furthermore it is an accepted procedure for treating both primary and permanent teeth with carious pulp exposures several materials have been using for capping the radicular pulp after pulpotomy these included formocresol glutaraldehyde ferric sulfate and mineral trioxide aggregate
Allium sativum is one of the most extensively researched medical plants and its antibacterial activity depends on allicin produced by the enzymatic activity of allinase a cysteine sulfoxide lyase Allicin and other thiosulfinates are believed to be responsible for the range of therapeutic effects reported for garlic Garlic extract has been reported to inhibit growth of various gram-positive and gram-negative bacteria Previous studies showed that A sativum oil is used as new pulp medications and it offers a good healing potential leaving the remaining pulp tissue healthy and functioning MTA is a unique material with various advantages It has been used successfully by pediatric dentists in a variety of clinical applications However its drawbacks especially its high cost discoloration potential difficulty in handling and long setting time
Allium sativum is one of the most extensively researched medical plants and its antibacterial activity depends on allicin produced by the enzymatic activity of allinase a cysteine sulfoxide lyase Allicin and other thiosulfinates are believed to be responsible for the range of therapeutic effects reported for garlic Garlic extract has been reported to inhibit growth of various gram-positive and gram-negative bacteria Previous studies showed that A sativum oil is used as new pulp medications and it offers a good healing potential leaving the remaining pulp tissue healthy and functioning MTA is a unique material with various advantages It has been used successfully by pediatric dentists in a variety of clinical applications However its drawbacks especially its high cost discoloration potential difficulty in handling and long setting time
Detailed Description:
1 Hypothesis This research adopts null hypothesis it assumes that the use of the both garlic oil dressed in zinc oxide powder and MTA as vital pulpotomy dressing material have the same effects
2 Trial design
Pilot study two arms split mouth design with 11 allocation ratio Patients clinical and radiographic outcomes assessors and statistician will be blinded in this study
3 Methods
Intervention
A Diagnostic procedure
Clinical examination will be done on the dental clinic using mirror and probe
Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth
Preoperative photographs will be taken
An individual XCP Extension Cone Paralleling index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs
Preoperative periapical radiograph will be taken
B Intra operative procedure
After randomly selecting which side will be in an intervention or control groups
Apply topical anaesthesia
Local anesthesia administration
Rubber dam application and access cavity preparation will be established using a sterile bur
Coronal pulp tissue will be removed using sharp large spoon excavator
Apply wet cotton pellet for few minutes
Then one side will be treated with Allium sativum oil dressed with zinc oxide powder -A sativum oil paste contralateral with MTA
Then a layer of zinc phosphate base will be placed over the dressing materials
After that those molars will be restored with stainless steel crowns and cemented using glass ionomer cement GIC
C Follow up
Follow up will be performed at 3 6 and 9 months according to guidelines for clinical and radiographic evaluation
D Criteria for discontinuing or modifying intervention
In case of unsuccessful outcomes of the intervention technique the case will be managed by MTA pulpectomy
E Strategies to improve adherence to intervention
Face to face sessions with the patients to stress on the importance of follow up
Oral hygiene measures
F Concomitant care Oral hygiene measures
4 Outcomes
-- --
1 ry outcome 1 Post-operative Pain Spontaneous pain and pain on biting will be reported by asking the patient using visual analogue scale
2 ry outcomes
-- --
1 Pain on percussionPresence or absence of pain will be detected by tapping on the tooth using back of mirror handle using visual analogue scale
2 Swelling
Presence or absence of swelling related to the affected tooth will be detected by visual intra-oral clinical examination
3 Sinus or fistulaPresence or absence of sinus or fistula related to the affected tooth will be detected by visual intra-oral clinical examination
4 Furcation involvementIt will be evaluated radiographically using DIGORA software using radiographic failure score
5 periapical radiolucency It will be evaluated radiographically using DIGORA software
6 Pathological internal or external root resorption It will be evaluated radiographically using DIGORA software
7 Widening of periodontal membrane spaceIt will be evaluated radiographically using DIGORA software
5- Recruitment Recruitment of the patients will be from the outpatient clinic of Pediatric Dentistry and Dental Public Health Department Cairo University Screening of patients will continue until the target population is achieved
6- Implementation Co-supervisor Randa Youssef Abd Al Gawad will assign which participant tooth will be included to either control or intervention groups according to the generated random sequence
7 Maskingblinding The statistician clinical and radiographic outcomes assessors will be blinded in this study
8 Data collection management and analysis Data collection method
Baseline data will be collected by the operator through a paper-based Case Report custom made form CRF which will be developed by the research team It will include the following items
1 Patient serial number
2 Demographic data
3 Patients medical history
Past medical history
Any present disease or illness
Current medication
Any specific pre-treatment medication
4 Past dental history
5 Records for current dental condition intra-oral examination and caries index
The custom made CRF will be developed before online registration of the study protocol CRF will be anonymous where patients will be identified by their serial number The full detailed personal data of the patient will be written in a separate sheet having the patients serial number for further contact with patient this sheet can be only seen by the operator and the supervisors The Co-supervisor Dr Randa Youssef Abd El-Gawad will have the role to monitor the process of data collection and check if there is any incomplete CRF
Primary and secondary outcomes will be collected by the lead researcher as follow
1 Pain spontaneous or on biting
Will be recorded by asking patient using visual analogue scale
2 Pain on percussion
Presence or absence will be detected by tapping the tooth with the back of the mirror using visual analogue scale
3 Swelling
Presence or absence will be detected by visual examination
4 Sinus or fistula
Presence or absence will be detected by visual examination
5 Widening in periodontal membrane space
6 furcation involvement or periapical radiolucency Presence or absence will be detected radiographically by Digora Image plate according to radiographic failure score
9- Data management Data will be entered on a software then stored online on a Google app Google drive Only the lead researcher will be allowed to enter the data and it will be revised by both senior and co supervisors Patient files will be stored in numerical order and stored in secure and accessible place and all data will be maintained in storage for 1 year after completion of the study
Plans to promote participant retention and complete follow- up
Telephone numbers of all patients included in the study will be recorded as a part of the written consent All patients will be given a phone call at the time of the pre-determined follow up dates
10 - Data monitoring Monitoring No formal data monitoring committee will be needed since most of studies in Faculty of Dentistry are with known minimal risks
11- Harms Any possible adverse effects of the interventions allergy to any of the used materials swelling sinus fistula pain or infection will be recorded
12- Audit
Procedures for auditing include
Participant enrolment
Consent
Eligibility criteria
Allocation to study groups
Adherence to trial interventions
Outcomes assessment
Auditing will be performed in order to preserve the integrity of the trial This will be ensured by periodic independent review of trial processes and documents by the Evidence Based Committee Faculty of Dentistry Cairo University IV Ethics and dissemination
13- Research ethics approval This protocol and the template informed consent forms appended to the protocol will be reviewed by the Ethics Committee of Scientific Research Faculty of Dentistry Cairo University
14- Protocol amendments The Ethics Committee and Evidence Based Committee Faculty of Dentistry Cairo University will be notified of any administrative changes or modifications of the protocol which may impact on the conduct of the study potential benefit of the patient or may affect patient safety including changes of study objectives study design sample sizes or study procedure
15- Informed consent Once the child is identified as eligible to the study by the clinical investigator the trial procedures benefits from the study and expected harms will be clearly discussed with parent or the childs legal guardian This explanation will be simplified with avoidance of any pain promoting words when the trial is discussed with the child Verbal assent will be obtained orally from the eligible child and the written consent will be signed by the childs guardians
16- Confidentiality Personal information about participants will be acquired during the process of trial recruitment eligibility screening and data collection Most of this information consists of private details All study-related information will be stored securely at the study site All participants information will be stored in locked file cabinets in areas with limited access All records that contain names or other personal identifiers will be stored separately from study records identified by code number All reports data collection process and administrative forms will be identified by the childs ID ticket serial number and will not contain any personal information to protect the participants confidentiality
17- Declaration of interest No known conflict of interests
18- Access to data Lead researcher Nourhan Omar Elgebaly will be given an access to the data sets All data sets will be password protected To ensure confidentiality data dispersed to project team members will be blinded of any identifying participant information
19- Ancillary and Post-trial care
Final restoration of the teeth participated at the trial will be done in the same visit
All patients will be followed up until 9 months
Full mouth treatment in addition to preventive measures will be offered for all participants
Patients will be instructed to follow up the teeth one year after the end of the trial
20- Dissemination policy
Study results will be published as partial fulfillment of the requirements for PHD degree in Pediatric Dentistry
The result of the trial are intended to be disseminated in the library of the Faculty and in the Egyptian Dental Journal
Topics suggested for presentation or publication will be circulated to the authors
If results show the advantage of one intervention over the other it will be recommended to be performed as a routine procedure during dental treatment
Thesis defence after completion of the study will be done in public with external judges
2 Trial design
Pilot study two arms split mouth design with 11 allocation ratio Patients clinical and radiographic outcomes assessors and statistician will be blinded in this study
3 Methods
Intervention
A Diagnostic procedure
Clinical examination will be done on the dental clinic using mirror and probe
Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth
Preoperative photographs will be taken
An individual XCP Extension Cone Paralleling index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs
Preoperative periapical radiograph will be taken
B Intra operative procedure
After randomly selecting which side will be in an intervention or control groups
Apply topical anaesthesia
Local anesthesia administration
Rubber dam application and access cavity preparation will be established using a sterile bur
Coronal pulp tissue will be removed using sharp large spoon excavator
Apply wet cotton pellet for few minutes
Then one side will be treated with Allium sativum oil dressed with zinc oxide powder -A sativum oil paste contralateral with MTA
Then a layer of zinc phosphate base will be placed over the dressing materials
After that those molars will be restored with stainless steel crowns and cemented using glass ionomer cement GIC
C Follow up
Follow up will be performed at 3 6 and 9 months according to guidelines for clinical and radiographic evaluation
D Criteria for discontinuing or modifying intervention
In case of unsuccessful outcomes of the intervention technique the case will be managed by MTA pulpectomy
E Strategies to improve adherence to intervention
Face to face sessions with the patients to stress on the importance of follow up
Oral hygiene measures
F Concomitant care Oral hygiene measures
4 Outcomes
-- --
1 ry outcome 1 Post-operative Pain Spontaneous pain and pain on biting will be reported by asking the patient using visual analogue scale
2 ry outcomes
-- --
1 Pain on percussionPresence or absence of pain will be detected by tapping on the tooth using back of mirror handle using visual analogue scale
2 Swelling
Presence or absence of swelling related to the affected tooth will be detected by visual intra-oral clinical examination
3 Sinus or fistulaPresence or absence of sinus or fistula related to the affected tooth will be detected by visual intra-oral clinical examination
4 Furcation involvementIt will be evaluated radiographically using DIGORA software using radiographic failure score
5 periapical radiolucency It will be evaluated radiographically using DIGORA software
6 Pathological internal or external root resorption It will be evaluated radiographically using DIGORA software
7 Widening of periodontal membrane spaceIt will be evaluated radiographically using DIGORA software
5- Recruitment Recruitment of the patients will be from the outpatient clinic of Pediatric Dentistry and Dental Public Health Department Cairo University Screening of patients will continue until the target population is achieved
6- Implementation Co-supervisor Randa Youssef Abd Al Gawad will assign which participant tooth will be included to either control or intervention groups according to the generated random sequence
7 Maskingblinding The statistician clinical and radiographic outcomes assessors will be blinded in this study
8 Data collection management and analysis Data collection method
Baseline data will be collected by the operator through a paper-based Case Report custom made form CRF which will be developed by the research team It will include the following items
1 Patient serial number
2 Demographic data
3 Patients medical history
Past medical history
Any present disease or illness
Current medication
Any specific pre-treatment medication
4 Past dental history
5 Records for current dental condition intra-oral examination and caries index
The custom made CRF will be developed before online registration of the study protocol CRF will be anonymous where patients will be identified by their serial number The full detailed personal data of the patient will be written in a separate sheet having the patients serial number for further contact with patient this sheet can be only seen by the operator and the supervisors The Co-supervisor Dr Randa Youssef Abd El-Gawad will have the role to monitor the process of data collection and check if there is any incomplete CRF
Primary and secondary outcomes will be collected by the lead researcher as follow
1 Pain spontaneous or on biting
Will be recorded by asking patient using visual analogue scale
2 Pain on percussion
Presence or absence will be detected by tapping the tooth with the back of the mirror using visual analogue scale
3 Swelling
Presence or absence will be detected by visual examination
4 Sinus or fistula
Presence or absence will be detected by visual examination
5 Widening in periodontal membrane space
6 furcation involvement or periapical radiolucency Presence or absence will be detected radiographically by Digora Image plate according to radiographic failure score
9- Data management Data will be entered on a software then stored online on a Google app Google drive Only the lead researcher will be allowed to enter the data and it will be revised by both senior and co supervisors Patient files will be stored in numerical order and stored in secure and accessible place and all data will be maintained in storage for 1 year after completion of the study
Plans to promote participant retention and complete follow- up
Telephone numbers of all patients included in the study will be recorded as a part of the written consent All patients will be given a phone call at the time of the pre-determined follow up dates
10 - Data monitoring Monitoring No formal data monitoring committee will be needed since most of studies in Faculty of Dentistry are with known minimal risks
11- Harms Any possible adverse effects of the interventions allergy to any of the used materials swelling sinus fistula pain or infection will be recorded
12- Audit
Procedures for auditing include
Participant enrolment
Consent
Eligibility criteria
Allocation to study groups
Adherence to trial interventions
Outcomes assessment
Auditing will be performed in order to preserve the integrity of the trial This will be ensured by periodic independent review of trial processes and documents by the Evidence Based Committee Faculty of Dentistry Cairo University IV Ethics and dissemination
13- Research ethics approval This protocol and the template informed consent forms appended to the protocol will be reviewed by the Ethics Committee of Scientific Research Faculty of Dentistry Cairo University
14- Protocol amendments The Ethics Committee and Evidence Based Committee Faculty of Dentistry Cairo University will be notified of any administrative changes or modifications of the protocol which may impact on the conduct of the study potential benefit of the patient or may affect patient safety including changes of study objectives study design sample sizes or study procedure
15- Informed consent Once the child is identified as eligible to the study by the clinical investigator the trial procedures benefits from the study and expected harms will be clearly discussed with parent or the childs legal guardian This explanation will be simplified with avoidance of any pain promoting words when the trial is discussed with the child Verbal assent will be obtained orally from the eligible child and the written consent will be signed by the childs guardians
16- Confidentiality Personal information about participants will be acquired during the process of trial recruitment eligibility screening and data collection Most of this information consists of private details All study-related information will be stored securely at the study site All participants information will be stored in locked file cabinets in areas with limited access All records that contain names or other personal identifiers will be stored separately from study records identified by code number All reports data collection process and administrative forms will be identified by the childs ID ticket serial number and will not contain any personal information to protect the participants confidentiality
17- Declaration of interest No known conflict of interests
18- Access to data Lead researcher Nourhan Omar Elgebaly will be given an access to the data sets All data sets will be password protected To ensure confidentiality data dispersed to project team members will be blinded of any identifying participant information
19- Ancillary and Post-trial care
Final restoration of the teeth participated at the trial will be done in the same visit
All patients will be followed up until 9 months
Full mouth treatment in addition to preventive measures will be offered for all participants
Patients will be instructed to follow up the teeth one year after the end of the trial
20- Dissemination policy
Study results will be published as partial fulfillment of the requirements for PHD degree in Pediatric Dentistry
The result of the trial are intended to be disseminated in the library of the Faculty and in the Egyptian Dental Journal
Topics suggested for presentation or publication will be circulated to the authors
If results show the advantage of one intervention over the other it will be recommended to be performed as a routine procedure during dental treatment
Thesis defence after completion of the study will be done in public with external judges
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