- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289971
Comparative Evaluation of Clinical and Radiographic Treatment Outcomes of Garlic Gel and Calcium Hydroxide as an Intracanal Medicament in Nonsurgical Root Canal Treatment of Permanent Teeth.
Comparative Evaluation of Clinical and Radiographic Treatment Outcomes of Garlic Gel and Calcium Hydroxide as an Intracanal Medicament in Nonsurgical Root Canal Treatment of Permanent Teeth: A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical trials are needed to evaluate the effectiveness of Allium sativum as an intracanal medicament due to its various useful properties, such as anti-inflammatory, wound healing action, and antimicrobial properties. To overcome the problems with synthetic medicament, researchers are looking for natural alternatives due to their low cost, easy availability, and safety. The objective of the study is to evaluate and compare the clinical and radiographic treatment outcomes of using garlic gel and calcium hydroxide paste as an intracanal medicament in nonsurgical root canal treatment of permanent teeth in terms of:
- Pain.
- Tenderness to palpation.
- Tenderness to percussion.
- Size of Periapical radiolucency.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Zara Rizwan, Bachelors of Dental Surgery
- Phone Number: +92 +923044232107
- Email: zararizwan95@gmail.com
Study Contact Backup
- Name: Shazia Naz, Masters of Dental Surgery
- Phone Number: +92 03214614543
- Email: drshazianaz210@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with the physical status of ASA I and ASA II according to ASA classification.
- Patients aged from 15-45 years.
- Mature permanent single-rooted teeth with closed apices.
- Patients with clinical signs of symptomatic apical periodontitis (pain, tenderness to palpation, and percussion).
- Patients having radiographic evidence of periapical radiolucency of endodontic origin.
- Patients who have not taken antibiotics for the past 14 days.
- Cooperative patients who show good compliance.
Exclusion Criteria:
- Patients with physical status of ASA III, IV, and V according to ASA classification.
- Teeth with a calcified pulp chamber in periapical radiography.
- Patients who have undergone previous endodontic treatment failure and those with the presence of sinus tract on clinical examination.
- Teeth having advanced periodontal disease, with the basic periodontal examination (BPE) of 3 and 4.
- Presence of internal and external resorption of the root as viewed on the periapical radiograph.
- Presence of vertical root fracture and perforation as viewed on the periapical radiograph
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group(n=48)
Garlic gel will be used as an intracanal medicament
|
Patients will receive informed consent, clinical exam, and preoperative radiographs.
After anesthesia and rubber dam isolation, access, cleaning, and shaping of canals will be performed using standard endodontic techniques.
A sterile paper point will be placed in the canal for pH evaluation, followed by placement of garlic gel with lentulo spiral and temporary restoration of MD Temp and GC Gold Label 2 GIC.
Patients will return after 14 days; if symptoms persist, the medicament will be replaced, and the patient will be reviewed again after 14 days and then after one month.
Final obturation will only be done once all symptoms have resolved.
If the experimental group continues to show symptoms after three dressings, the case will be considered a failure and treated conventionally.
When asymptomatic, the medicament will be removed, canals will be irrigated, dried, obturated with gutta-percha and Endoplus sealer.
Radiographic outcomes will be evaluated after 6 months by 2 endodontists.
|
|
Active Comparator: Control group(n=48)
Patients will receive informed consent, clinical exam, and preoperative radiographs.
After anesthesia and rubber dam isolation, access, cleaning, and shaping of canals will be performed using standard endodontic techniques.
Calcium hydroxide (control) will be placed as intracanal medicament, followed by temporary restoration of Cavit and Glass Ionomer cement.
After 14 days, if clinical symptoms of pain, tenderness to palpation and percussion resolve, the medicament will be removed, and the canal will be obturated and permanently restored.
However, if the patient remains clinically symptomatic, then another dressing of calcium hydroxide will be placed.
Finally, clinical outcomes will be recorded after a month and obturation will be delayed until the complete resolution of clinical signs and symptoms.
Patients will return after 6 months for clinical and radiographic evaluation, with pre- and postoperative radiographs compared by two endodontists.
|
Patients will receive informed consent, clinical exam, and preoperative radiographs.
After anesthesia and rubber dam isolation, access, cleaning, and shaping of canals will be performed using standard endodontic techniques.
A sterile paper point will be placed in the canal for pH evaluation, followed by placement of garlic gel with lentulo spiral and temporary restoration of MD Temp and GC Gold Label 2 GIC.
Patients will return after 14 days; if symptoms persist, the medicament will be replaced, and the patient will be reviewed again after 14 days and then after one month.
Final obturation will only be done once all symptoms have resolved.
If the experimental group continues to show symptoms after three dressings, the case will be considered a failure and treated conventionally.
When asymptomatic, the medicament will be removed, canals will be irrigated, dried, obturated with gutta-percha and Endoplus sealer.
Radiographic outcomes will be evaluated after 6 months by 2 endodontists.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CLINICAL AND RADIOGRAPHIC OUTCOMES
Time Frame: Time frame for clinical outcomes: Baseline to 2 weeks Time frame for radiographic outcomes: Baseline to 6 months
|
Clinical success will be based on the absence of the following clinical signs and symptoms: Pain Tenderness to palpation of adjacent soft tissues Tenderness to percussion of involved tooth Radiographic outcomes will be measured in terms of size of Periapical radiolucency. The Periapical status will be assessed using the periapical index (PAI) scoring system by Orstavik. Each tooth will be assigned one of the Periapical index scores for 5 categories within the scale. SCORE POSSIBLE OUTCOME
Periapical radiolucency will be classified as resolved if the Periapical index score is less than or equal to score of 2. |
Time frame for clinical outcomes: Baseline to 2 weeks Time frame for radiographic outcomes: Baseline to 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zara Rizwan, Bachelors of Dental Surgery, University of Health Science
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00/220/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Study Protocol
Information identifier: PMID: 35852013Information comments: https://pubmed.ncbi.nlm.nih.gov/
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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