Apical PeriodontitisNCT07679880
Retreatment and Diabetes
A study testing root canal retreatment in people with Apical Periodontitis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
ABSTRACT This prospective, controlled, single-center clinical study aims to compare postoperative pain levels and analgesic consumption after nonsurgical endodontic retreatment in individuals with diabetes mellitus and systemically healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- root canal retreatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 60 years. Patients classified as medically healthy (ASA I) for the control group or as having diabetes mellitus (ASA II or ASA III) for the diabetes mellitus group.
- Single-rooted, single-canal teeth with closed apices. Teeth with previous root canal treatment completed at least 4 years before enrollment.
- Teeth with root canal filling ending 1 to 4 mm coronal to the radiographic apex.
- Teeth diagnosed with asymptomatic apical periodontitis. Teeth with a periapical index score between 2 and 4. Teeth without pain on percussion or palpation. Teeth not requiring periodontal or prosthetic treatment. Teeth suitable for rubber dam isolation.
Who cannot join
- Use of analgesics, antibiotics, or corticosteroids within the last 2 weeks before nonsurgical endodontic retreatment.
- Teeth with periodontal attachment loss. Teeth with vertical root fracture, external root resorption, or perforation. Teeth with fractured prosthetic restorations. Non-restorable teeth. Patients with severe pain and/or acute apical abscess. Pregnant patients. Teeth with calcified root canals. Individuals considered unable to comply with treatment procedures because of intellectual disability, developmental delay, or advanced age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nonsurgical Endodontic Retreatment on Postoperative Pain in Patients With Diabetes Mellitus: A Prospective Clinical Study
ABSTRACT This prospective, controlled, single-center clinical study aims to compare postoperative pain levels and analgesic consumption after nonsurgical endodontic retreatment in individuals with diabetes mellitus and systemically healthy individuals. In addition, the study aims to evaluate the relationship between HbA1c levels, type of antidiabetic medication, and postoperative pain within the diabetes mellitus group.
A total of 54 patients with single-rooted teeth requiring nonsurgical endodontic retreatment due to persistent endodontic problems following previous root canal treatment will be included. Participants will be allocated into two groups according to systemic status: a diabetes mellitus group and a systemically healthy control group, with 27 patients in each group.
Read more
All retreatment procedures will be performed by a single operator using a standardized clinical protocol. Previous root canal filling materials will be removed, root canals will be reshaped, irrigated according to a standardized irrigation protocol, and obturated using an epoxy resin-based root canal sealer and gutta-percha cones with the cold lateral condensation technique.
Postoperative pain will be assessed using a Visual Analog Scale at 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7. Analgesic consumption will be recorded at the same follow-up time points. Intergroup comparisons, changes in pain scores over time, and associations between HbA1c levels, antidiabetic medication type, and postoperative pain will be evaluated using appropriate statistical tests. The statistical significance level will be set at p < 0.05.
- Conditions
- Apical Periodontitis
- Being tested
- root canal retreatment
- Keywords
- endodontics, diabetes mellitus, retreatment
- Medical subject headings
- Periapical Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal retreatmentProcedure or surgery
root canal retreatment
| Study group | Role | What they receive |
|---|---|---|
| Patient with Diabetes mellitus | Experimental | Not described Receives: Procedure: root canal retreatment |
| Healty patient | Experimental | Not described Receives: Procedure: root canal retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed using the 100-mm Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 mm, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater postoperative pain intensity. Pain will be recorded at each scheduled follow-up assessment.
Measured: 6, 12, 24, and 48 hours after nonsurgical endodontic retreatment and on postoperative days 3, 4, 5, 6, and 7
Secondary outcomes (2)
Analgesic consumption after nonsurgical endodontic retreatment
Analgesic consumption will be recorded at 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7. Participants will record each dose of 400 mg ibuprofen taken for postoperative pain. Higher values indicate greater analgesic consumption.
Measured: 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7.
Association between HbA1c level and postoperative pain intensity
The association between glycated hemoglobin (HbA1c) levels and postoperative pain intensity measured using the 100-mm Visual Analog Scale (VAS) will be evaluated in participants with diabetes mellitus.
Measured: HbA1c level assessed at baseline; postoperative pain assessed at 6, 12, 24, and 48 hours and on postoperative days 3, 4, 5, 6, and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- Study completion1 Apr 2026
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek Eraslan Akyuz, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679880
- Sponsor's protocol ID
- 2025/336
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nonsurgical Endodontic Retreatment on Postoperative Pain in Patients With Diabetes Mellitus: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07679880
- Acronym / sponsor ID
- 2025/336
- Conditions
- Apical Periodontitis
- Keywords
- endodontics, diabetes mellitus, retreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 1 Jul 2026 (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.
ABSTRACT This prospective, controlled, single-center clinical study aims to compare postoperative pain levels and analgesic consumption after nonsurgical endodontic retreatment in individuals with diabetes mellitus and systemically healthy individuals. In addition, the study aims to evaluate the relationship between HbA1c levels, type of antidiabetic medication, and postoperative pain within the diabetes mellitus group.
A total of 54 patients with single-rooted teeth requiring nonsurgical endodontic retreatment due to persistent endodontic problems following previous root canal treatment will be included. Participants will be allocated into two groups according to systemic status: a diabetes mellitus group and a systemically healthy control group, with 27 patients in each group.
All retreatment procedures will be performed by a single operator using a standardized clinical protocol. Previous root canal filling materials will be removed, root canals will be reshaped, irrigated according to a standardized irrigation protocol, and obturated using an epoxy resin-based root canal sealer and gutta-percha cones with the cold lateral condensation technique.
Postoperative pain will be assessed using a Visual Analog Scale at 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7. Analgesic consumption will be recorded at the same follow-up time points. Intergroup comparisons, changes in pain scores over time, and associations between HbA1c levels, antidiabetic medication type, and postoperative pain will be evaluated using appropriate statistical tests. The statistical significance level will be set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Diabetes mellitus | Experimental | Procedure: root canal retreatment |
| Healty patient | Experimental | Procedure: root canal retreatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 60 years. Patients classified as medically healthy (ASA I) for the control group or as having diabetes mellitus (ASA II or ASA III) for the diabetes mellitus group.
- Single-rooted, single-canal teeth with closed apices. Teeth with previous root canal treatment completed at least 4 years before enrollment.
- Teeth with root canal filling ending 1 to 4 mm coronal to the radiographic apex.
- Teeth diagnosed with asymptomatic apical periodontitis. Teeth with a periapical index score between 2 and 4. Teeth without pain on percussion or palpation. Teeth not requiring periodontal or prosthetic treatment. Teeth suitable for rubber dam isolation.
Key exclusion criteria (2 listed)
- Use of analgesics, antibiotics, or corticosteroids within the last 2 weeks before nonsurgical endodontic retreatment.
- Teeth with periodontal attachment loss. Teeth with vertical root fracture, external root resorption, or perforation. Teeth with fractured prosthetic restorations. Non-restorable teeth. Patients with severe pain and/or acute apical abscess. Pregnant patients. Teeth with calcified root canals. Individuals considered unable to comply with treatment procedures because of intellectual disability, developmental delay, or advanced age.
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 |
|---|---|---|
| root canal retreatmentroot canal retreatment | Procedure or surgery | Healty patient, Patient with Diabetes mellitus |
Primary outcome
Postoperative pain intensity assessed using the 100-mm Visual Analog Scale (VAS)
Time frame: 6, 12, 24, and 48 hours after nonsurgical endodontic retreatment and on postoperative days 3, 4, 5, 6, and 7
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 mm, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater postoperative pain intensity. Pain will be recorded at each scheduled follow-up assessment.
2 secondary outcomes
Analgesic consumption after nonsurgical endodontic retreatment
Time frame: 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7.
Association between HbA1c level and postoperative pain intensity
Time frame: HbA1c level assessed at baseline; postoperative pain assessed at 6, 12, 24, and 48 hours and on postoperative days 3, 4, 5, 6, and 7.
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
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Apical Periodontitis, Postoperative Pain After Endodontic Treatment
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Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
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Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
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Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal retreatment in people with Apical Periodontitis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 2 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 1 Jul 2026. 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 Turkey (Türkiye). 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.
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?
Postoperative pain intensity assessed using the 100-mm Visual Analog Scale (VAS) (time frame: 6, 12, 24, and 48 hours after nonsurgical endodontic retreatment and on postoperative days 3, 4, 5, 6, and 7). 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 1 Jul 2026.