Apical PeriodontitisPhase 2/3NCT06766201
Effect of Use of Calcium Hydroxide and Metformin Intracanal Medicament After NSRCT
A Phase 2/3 study testing Metformin in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Goal of this randomized clinical trial is evaluate the effect of Calcium Hydroxide and Metformin Intracanal Medicament on periapical healing after NSRCT. Population includes systemically healthy patient with radiographic evidence of apical periodontitis PAI score more then 3 will be recruited . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 1 Jan 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mature permanent mandibular molar with necrotic pulp (absence of response to cold and electric pulp tester) and apical periodontitis requiring primary root canal treatment with radiographic evidence of periapical radiolucency (periapical index score ≥ 3).
- Age - Above 18 years
- Non-contributory medical history (ASA 1)
- Periodontally healthy tooth (probing depth <4mm)
Who cannot join
- Patients who do not provide authorization for participation in the study
- History of analgesic intake in the previous 1 week, or antibiotic intake in 1 month
- Mandibular molar with no opposing teeth.
- Patients whose tooth had been previously accessed or endodontically treated.
- Patient on systemic MF or medication that interfere periapical healing
- Presence of bleeding on opening of pulp chamber.
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- Diabetic, immunocompromised and pregnant patient.
- Teeth with cracks, fracture, internal and external resorption.
- Any medications that alter bone metabolism such as, immunosuppressive drugs, corticosteroids, hormone replacement therapy ,selective serotonin reuptake inhibitors, intravenous bisphosphonates, and/or antiresorptive treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Use of Calcium Hydroxide and Metformin as Intracanal Dressings in Healing of Apical Periodontitis in Mature Permanent Mandibular Molars: A Randomized Clinical Trial
Goal of this randomized clinical trial is evaluate the effect of Calcium Hydroxide and Metformin Intracanal Medicament on periapical healing after NSRCT. Population includes systemically healthy patient with radiographic evidence of apical periodontitis PAI score more then 3 will be recruited . Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period.
Read the detailed description
AIM: To compare the efficacy of calcium hydroxide and metformin intracanal medicaments in healing of apical periodontitis in mature permanent mandibular molars. Objectives Primary objective: To determine the effect of calcium hydroxide and metformin intracanal medicaments on healing of apical periodontitis in mature permanent mandibular molars using periapical index (PAI) score. Secondary objective: assess postoperative pain after chemo mechanical preparation and intracanal dressing of calcium hydroxide or metformin using visual analogue scale (VAS)
Clinical procedure Mature permanent mandibular teeth with diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) will be chosen for the study. 17 Patients will be randomly allocated to either of the two groups- Group A (calcium hydroxide), Group B (Metformin). The tooth will be anesthetized using 2% lidocaine with 1:100000 adrenaline followed by rubber dam isolation. Caries excavation will be done and access cavity will be made. Coronal flaring \& enlargement will be performed with rotary NiTi orifice enlargers to obtain straight -line access to the apical third of each root. Hand files No. 10, 15 and 20 will be used till working length (WL) to prepare a smooth reproducible glide path Working length will be obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. Canals will be then prepared using the Crown down technique with rotary instruments.
5ml of 5.25% sodium hypochlorite is used as irrigate after each instrument. After completion of canal instrumentation, all canal will be irrigated with 17% ethylenediamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Patency will maintained by placing a 10 k file 1 mm beyond the apical foramen after each instrument change. Canals will be dried with absorbent paper points and filled with a Calcium hydroxide with propylene glycol in control group A and will be filled with 1% Metformin with propylene glycol in control group B .Both paste will be paced in canal by lentulospiral and the access cavity restored with intermediate restorative material (IRM). The patient will be recalled after 1 week and evaluated for post operative pain.
At the next appointment, the paste will be removed with H- files and copious irrigation with 5.25% NaOCl; and dried with paper points. Canals will be obturated with the Gutta Percha and Zinc Oxide- Eugenol based sealer.
After obturation, the cavity will be restored . Immediate postoperative radiograph will then be taken. Follow up clinical and radiographic examinations will be carried out at 6 month \& 12 month period.
- Conditions
- Apical Periodontitis
- Being tested
- Metformin
- Keywords
- AP, metformin, calcium hydroxide, medicament
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called MF
Metformin mixed with propylene glycol
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide group | No intervention | Calcium hydroxide is mixed with propylene glycol |
| metformin group | Experimental | metformin mixed with propylene glycol Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
periapical healing using the Periapical index score
clinical and radiographic healing clinical and radiographic success at 6 and12 months follow .
Measured: 6 and12 months follow .
Secondary outcomes (1)
Clinical success
Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements
Measured: 6 and12 months follow .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Aug 2023
- Primary completion1 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
- Investigators
- Dr. Sanjay Tewari, MDS, Study director, Post Graduate Institute Of Dental Sciences,Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766201
- Sponsor's protocol ID
- AMBIKA TEKTA
- Status last verified
- May 2025
- First submitted
- 4 Jun 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Use of Calcium Hydroxide and Metformin as Intracanal Dressings in Healing of Apical Periodontitis in Mature Permanent Mandibular Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06766201
- Acronym / sponsor ID
- AMBIKA TEKTA
- Conditions
- Apical Periodontitis
- Keywords
- AP, metformin, calcium hydroxide, medicament
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 9 Jan 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.
Goal of this randomized clinical trial is evaluate the effect of Calcium Hydroxide and Metformin Intracanal Medicament on periapical healing after NSRCT. Population includes systemically healthy patient with radiographic evidence of apical periodontitis PAI score more then 3 will be recruited . Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period.
Detailed description
AIM: To compare the efficacy of calcium hydroxide and metformin intracanal medicaments in healing of apical periodontitis in mature permanent mandibular molars. Objectives Primary objective: To determine the effect of calcium hydroxide and metformin intracanal medicaments on healing of apical periodontitis in mature permanent mandibular molars using periapical index (PAI) score. Secondary objective: assess postoperative pain after chemo mechanical preparation and intracanal dressing of calcium hydroxide or metformin using visual analogue scale (VAS)
Clinical procedure Mature permanent mandibular teeth with diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) will be chosen for the study. 17 Patients will be randomly allocated to either of the two groups- Group A (calcium hydroxide), Group B (Metformin). The tooth will be anesthetized using 2% lidocaine with 1:100000 adrenaline followed by rubber dam isolation. Caries excavation will be done and access cavity will be made. Coronal flaring \& enlargement will be performed with rotary NiTi orifice enlargers to obtain straight -line access to the apical third of each root. Hand files No. 10, 15 and 20 will be used till working length (WL) to prepare a smooth reproducible glide path Working length will be obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. Canals will be then prepared using the Crown down technique with rotary instruments.
5ml of 5.25% sodium hypochlorite is used as irrigate after each instrument. After completion of canal instrumentation, all canal will be irrigated with 17% ethylenediamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Patency will maintained by placing a 10 k file 1 mm beyond the apical foramen after each instrument change. Canals will be dried with absorbent paper points and filled with a Calcium hydroxide with propylene glycol in control group A and will be filled with 1% Metformin with propylene glycol in control group B .Both paste will be paced in canal by lentulospiral and the access cavity restored with intermediate restorative material (IRM). The patient will be recalled after 1 week and evaluated for post operative pain.
At the next appointment, the paste will be removed with H- files and copious irrigation with 5.25% NaOCl; and dried with paper points. Canals will be obturated with the Gutta Percha and Zinc Oxide- Eugenol based sealer.
After obturation, the cavity will be restored . Immediate postoperative radiograph will then be taken. Follow up clinical and radiographic examinations will be carried out at 6 month \& 12 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide group | No intervention | –Calcium hydroxide is mixed with propylene glycol |
| metformin group | Experimental | Drug: Metforminmetformin mixed with propylene glycol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mature permanent mandibular molar with necrotic pulp (absence of response to cold and electric pulp tester) and apical periodontitis requiring primary root canal treatment with radiographic evidence of periapical radiolucency (periapical index score ≥ 3).
- Age - Above 18 years
- Non-contributory medical history (ASA 1)
- Periodontally healthy tooth (probing depth <4mm)
Key exclusion criteria (9 listed)
- Patients who do not provide authorization for participation in the study
- History of analgesic intake in the previous 1 week, or antibiotic intake in 1 month
- Mandibular molar with no opposing teeth.
- Patients whose tooth had been previously accessed or endodontically treated.
- Patient on systemic MF or medication that interfere periapical healing
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 |
|---|---|---|
| MetforminAlso: MFMetformin mixed with propylene glycol | Drug | metformin group |
Primary outcome
periapical healing using the Periapical index score
Time frame: 6 and12 months follow .
clinical and radiographic healing clinical and radiographic success at 6 and12 months follow .
1 secondary outcome
Clinical success
Time frame: 6 and12 months follow .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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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)
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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. This study is not recruiting at the moment.
Dr. Sanjay Tewari, MDS study director
Post Graduate Institute Of Dental Sciences,Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periapical healing using the Periapical index score (time frame: 6 and12 months follow .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.