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.

January 1, 2026 updated by: Zara Rizwan, University of Health Sciences Lahore

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.

Researchers want to check how well garlic works inside permanent teeth as a medicament during root canal treatments. Garlic has shown to possess many helpful properties, like reducing inflammation, helping wounds heal, and antimicrobial characteristics. Because conventional medicaments can be expensive or have potential side effects, researchers are actively exploring natural options like garlic. Some lab studies have already shown that garlic gel can kill the microbes inside the teeth. However, no real-life clinical or X-ray studies have been done on using garlic in permanent teeth. This study may help scientists find a much safer and effective new material for dental treatments in the future.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zara Rizwan, Bachelors of Dental Surgery
  • Phone Number: +92 +923044232107
  • Email: zararizwan95@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group(n=48)
Garlic gel will be used as an intracanal medicament
Drug: Allium Sativum 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.
Drug: Allium Sativum 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

  1. Normal periapical structure
  2. Small changes in bone structures
  3. Change in bone structure with mineral loss
  4. Periodontitis with well-defined radiolucency
  5. Severe periodontitis with exacerbating features

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Health Sciences Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zara Rizwan, Bachelors of Dental Surgery, University of Health Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00/220/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing IPD in a way that compromises privacy would violate patient consent agreements and breach significant global privacy laws.

Study Data/Documents

  1. Study Protocol
    Information identifier: PMID: 35852013
    Information comments: https://pubmed.ncbi.nlm.nih.gov/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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