Apical PeriodontitisPhase 3NCT07289971
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 Phase 3 study testing Allium Sativum as an intracanal medicament in people with Apical Periodontitis and Periapical Radiolucency, run by University of Health Sciences Lahore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Periapical Radiolucency
- What is being tested?
- Allium Sativum as an intracanal medicament
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Apical Periodontitis, Periapical Radiolucency
- Being tested
- Allium Sativum as an intracanal medicament
- Keywords
- Intracanal Medicament, Allium Sativum, Calcium hydroxide, Root canal treatment, Periapical Index, Resolution of Periapical Radiolucency, Visual Analogue Scale, Palpation, Percussion
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium Sativum as an intracanal medicamentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group(n=48) | Experimental | Garlic gel will be used as an intracanal medicament Receives: Drug: Allium Sativum as an intracanal medicament |
| Control group(n=48) | Active comparator | 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. Receives: Drug: Allium Sativum as an intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL AND RADIOGRAPHIC OUTCOMES
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
- Normal periapical structure
- Small changes in bone structures
- Change in bone structure with mineral loss
- Periodontitis with well-defined radiolucency
- 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.
Measured: Time frame for clinical outcomes: Baseline to 2 weeks Time frame for radiographic outcomes: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded parallel arm randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zara Rizwan, University of Health Sciences Lahore
- Investigators
- Zara Rizwan, Bachelors of Dental Surgery, Principal investigator, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289971
- Sponsor's protocol ID
- 00/220/22
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD in a way that compromises privacy would violate patient consent agreements and breach significant global privacy laws.
Publications
Faghihi T, Haghgoo R, Taghizade F, Zareiyan M, Mehran M, Ansari G. The clinical and radiographic evaluation of Allium sativum oil (garlic oil) in comparison with mineral trioxide aggregate in primary molar pulpotomy. Dent Res J (Isfahan). 2021 Nov 22;18:100. doi: 10.4103/1735-3327.330881. eCollection 2021.
PubMed 35003565
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07289971
- Acronym / sponsor ID
- 00/220/22
- Conditions
- Apical Periodontitis, Periapical Radiolucency
- Keywords
- Intracanal Medicament, Allium Sativum, Calcium hydroxide, Root canal treatment, Periapical Index, Resolution of Periapical Radiolucency, Visual Analogue Scale, Palpation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded parallel arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group(n=48) | Experimental | Drug: Allium Sativum as an intracanal medicamentGarlic gel will be used as an intracanal medicament |
| Control group(n=48) | Active comparator | Drug: Allium Sativum as an intracanal medicamentPatients 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allium Sativum as an intracanal medicamentPatients 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. | Drug | Control group(n=48), Experimental group(n=48) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 35003565Faghihi T, Haghgoo R, Taghizade F, Zareiyan M, Mehran M, Ansari G. The clinical and radiographic evaluation of Allium sativum oil (garlic oil) in comparison with mineral trioxide aggregate in primary molar pulpotomy. Dent Res J (Isfahan). 2021 Nov 22;18:100. doi: 10.4103/1735-3327.330881. eCollection 2021.
- Arruda, M., Neves, M., Diogenes, A., Mdala, I., Guilherme, B., Siqueira, J. and Rôças, I., 2018. Infection control in teeth with apical periodontitis using triple antibiotic solution or calcium hydroxide with chlorhexidine: A Randomized ControLink provided by the sponsor.
- Individual participant dataSharing planned: No. Sharing IPD in a way that compromises privacy would violate patient consent agreements and breach significant global privacy laws.
Related trials for Apical Periodontitis
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zara Rizwan, Bachelors of Dental Surgery principal investigator
University of Health science
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allium Sativum as an intracanal medicament in people with Apical Periodontitis and Periapical Radiolucency, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zara Rizwan, Bachelors of Dental Surgery (+923044232107 ext. +92, zararizwan95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL AND RADIOGRAPHIC OUTCOMES (time frame: Time frame for clinical outcomes: Baseline to 2 weeks Time frame for radiographic outcomes: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07289971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.