Diabetes MellitusRCT-DM-PainNCT07271511
Postoperative Pain After Single vs Multiple-Visit Root Canal Treatment in Diabetic Patients
A study testing Single-Visit Root Canal Therapy and Multiple-Visit Root Canal Therapy in people with Diabetes Mellitus and Postoperative Pain After Endodontic Treatment, run by College of Physicians and Surgeons Pakistan.
Trial summary
A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Postoperative Pain After Endodontic Treatment
- What is being tested?
- Single-Visit Root Canal Therapy and Multiple-Visit Root Canal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 Jun 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 1 or Type 2 Diabetes Mellitus.
- In need of root canal treatment on a single-rooted tooth.
- A clinical diagnosis of either irreversible pulpitis or necrotic pulp in the indicated tooth.
- Willingness and ability to understand and provide written informed consent (and assent with parental consent for minors).
- -
Who cannot join
- Pregnancy.
- Known history of allergy to local anesthetics.
- Presence of large periapical radiolucent lesions (typically defined as >5mm in diameter).
- Current use of long-term analgesic or anti-inflammatory medication (which could alter pain perception).
- Teeth with complex root canal anatomy (e.g., calcified canals, C-shaped canals) that would complicate standard treatment.
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 Analysis of Postoperative Pain Following Single vs Multiple-Visit Root Canal Therapy in Single-Rooted Teeth of Diabetic Patients: A Randomized Controlled Trial
A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.
Read the detailed description
This study compares post-treatment pain after root canal therapy done in one visit versus two visits for patients with diabetes. Root canal treatment can sometimes cause pain afterwards, and it is unclear if the number of visits makes a difference, especially for diabetic patients who may have different healing and pain responses. We will randomly assign 200 diabetic patients needing a root canal on a single-rooted tooth to either have the entire procedure completed in a single appointment or split over two appointments. Patients will record their pain levels on a standard scale at 24 hours, 72 hours, and one week after the procedure. We hypothesize that there will be no significant difference in pain levels between the two treatment approaches. The results will help dentists decide the best treatment plan for their diabetic patients without worrying about causing more pain.
- Being tested
- Single-Visit Root Canal Therapy, Multiple-Visit Root Canal Therapy
- Keywords
- Single-Visit Endodontics, Multiple-Visit Endodontic, Root canal therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Visit Root Canal TherapyProcedure or surgery
A standard non-surgical root canal treatment protocol where the entire procedure-from access opening and canal instrumentation to final obturation-is completed in one continuous session, without the use of inter-appointment intracanal medication
Multiple-Visit Root Canal TherapyProcedure or surgery
A standard non-surgical root canal treatment protocol performed over two clinical appointments. The first visit involves canal preparation and dressing with an intracanal medicament. The final visit, scheduled after an interim period, involves the removal of the medicament and the completion of the root canal filling.
| Study group | Role | What they receive |
|---|---|---|
| Single-Visit RCT | Experimental | Participants in this arm receive the complete root canal therapy procedure in a single clinical appointment. This includes local anesthesia, rubber dam isolation, access cavity preparation, biomechanical cleaning and shaping of the root canal system, and final obturation (filling) of the canal Receives: Procedure: Single-Visit Root Canal Therapy |
| Multiple-Visit RCT | Active comparator | Participants in this arm receive root canal therapy over two separate appointments. The first visit includes local anesthesia, rubber dam isolation, access cavity preparation, and biomechanical cleaning and shaping of the root canal system, followed by the placement of an intracanal medication and a temporary restoration. The second visit involves the removal of the temporary material and the final obturation (filling) of the canal Receives: Procedure: Single-Visit Root Canal Therapy; Procedure: Multiple-Visit Root Canal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation
Measurement Tool: Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst imaginable pain).
Unit of Measure: Percentage (%) of patients.
Description: The proportion of patients reporting a pain intensity score of 4 or greater on the NRS during movement (e.g., coughing or ambulation) at the 24-hour post-operative time point.
Measured: 24 Hours after the procedure
Secondary outcomes (1)
Mean Resting Pain Intensity at 24 Hours Post-Operation
Measurement Tool: Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst imaginable pain).
Unit of Measure: Percentage (%) of patients.
Description: The proportion of patients reporting a pain intensity score of 4 or greater on the NRS during movement (e.g., coughing or ambulation) at the 24-hour post-operative time point.
Measured: 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 May 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Participants are assigned to receive either the single-visit or multiple-visit root canal therapy and are followed identically over the same time period.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiz ur rahman, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271511
- Sponsor's protocol ID
- KCD-Endo-DM-001
- Acronym
- RCT-DM-Pain
- Status last verified
- Mar 2026
- First submitted
- 22 Nov 2025
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Postoperative Pain Following Single vs Multiple-Visit Root Canal Therapy in Single-Rooted Teeth of Diabetic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07271511
- Acronym / sponsor ID
- RCT-DM-Pain / KCD-Endo-DM-001
- Keywords
- Single-Visit Endodontics, Multiple-Visit Endodontic, Root canal therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 9 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.
A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.
Detailed description
This study compares post-treatment pain after root canal therapy done in one visit versus two visits for patients with diabetes. Root canal treatment can sometimes cause pain afterwards, and it is unclear if the number of visits makes a difference, especially for diabetic patients who may have different healing and pain responses. We will randomly assign 200 diabetic patients needing a root canal on a single-rooted tooth to either have the entire procedure completed in a single appointment or split over two appointments. Patients will record their pain levels on a standard scale at 24 hours, 72 hours, and one week after the procedure. We hypothesize that there will be no significant difference in pain levels between the two treatment approaches. The results will help dentists decide the best treatment plan for their diabetic patients without worrying about causing more pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Participants are assigned to receive either the single-visit or multiple-visit root canal therapy and are followed identically over the same time period.
| Arm | Type | Receives |
|---|---|---|
| Single-Visit RCT | Experimental | Procedure: Single-Visit Root Canal TherapyParticipants in this arm receive the complete root canal therapy procedure in a single clinical appointment. This includes local anesthesia, rubber dam isolation, access cavity preparation, biomechanical cleaning and shaping of the root canal system, and final obturation (filling) of the canal |
| Multiple-Visit RCT | Active comparator | Procedure: Single-Visit Root Canal Therapy, Procedure: Multiple-Visit Root Canal TherapyParticipants in this arm receive root canal therapy over two separate appointments. The first visit includes local anesthesia, rubber dam isolation, access cavity preparation, and biomechanical cleaning and shaping of the root canal system, followed by the placement of an intracanal medication and a temporary restoration. The second visit involves the removal of the temporary material and the final obturation (filling) of the canal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Type 1 or Type 2 Diabetes Mellitus.
- In need of root canal treatment on a single-rooted tooth.
- A clinical diagnosis of either irreversible pulpitis or necrotic pulp in the indicated tooth.
- Willingness and ability to understand and provide written informed consent (and assent with parental consent for minors).
- -
Key exclusion criteria (5 listed)
- Pregnancy.
- Known history of allergy to local anesthetics.
- Presence of large periapical radiolucent lesions (typically defined as >5mm in diameter).
- Current use of long-term analgesic or anti-inflammatory medication (which could alter pain perception).
- Teeth with complex root canal anatomy (e.g., calcified canals, C-shaped canals) that would complicate standard treatment.
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 |
|---|---|---|
| Single-Visit Root Canal TherapyA standard non-surgical root canal treatment protocol where the entire procedure-from access opening and canal instrumentation to final obturation-is completed in one continuous session, without the use of inter-appointment intracanal medication | Procedure or surgery | Multiple-Visit RCT, Single-Visit RCT |
| Multiple-Visit Root Canal TherapyA standard non-surgical root canal treatment protocol performed over two clinical appointments. The first visit involves canal preparation and dressing with an intracanal medicament. The final visit, scheduled after an interim period, involves the removal of the medicament and the completion of the root canal filling. | Procedure or surgery | Multiple-Visit RCT |
Primary outcome
Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation
Time frame: 24 Hours after the procedure
Measurement Tool: Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). Unit of Measure: Percentage (%) of patients. Description: The proportion of patients reporting a pain intensity score of 4 or greater on the NRS during movement (e.g., coughing or ambulation) at the 24-hour post-operative time point.
1 secondary outcome
Mean Resting Pain Intensity at 24 Hours Post-Operation
Time frame: 24 hours after the procedure
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Visit Root Canal Therapy and Multiple-Visit Root Canal Therapy in people with Diabetes Mellitus and Postoperative Pain After Endodontic Treatment, run by College of Physicians and Surgeons Pakistan.
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 5 inclusion and 5 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 18 Mar 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.
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 Madeeha murtaza (+923400178482, madi.shahid14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation (time frame: 24 Hours after the procedure). 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 18 Mar 2026.