Deep Caries Clinical Trial
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)
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.
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 1:1 allocation ratio. Patient's, 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 percussion:Presence 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 fistula:Presence or absence of sinus or fistula related to the affected tooth
will be detected by visual intra-oral clinical examination.
4. Furcation involvement:It 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 space:It 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. Masking/blinding: 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 patient's 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 child's 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 child's 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 child's
ID (ticket serial number) and will not contain any personal information to protect the
participant's 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.
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