Apical PeriodontitisNCT07466433
Apical Preparation Size in Regenerative Endodontics of Mature Teeth
A study testing Regenerative Endodontic Treatment in people with Apical Periodontitis and Mature Teeth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Apical Periodontitis, Mature Teeth, Regenerative Endodontic Treatment
- What is being tested?
- Regenerative Endodontic Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2024to 23 Oct 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Single-rooted mature teeth with periapical lesions
- Teeth with a PAI score ≥ 3
- Patients aged 18-45 years
- Systemically healthy individuals
- Patients who provided written informed consent
Who cannot join
- Immature teeth
- Previously root canal treated teeth
- Teeth with a PAI score <3
- Developmental anomalies
- Advanced periodontal destruction
- Internal/external resorption
Show all 9Show fewer
- History of trauma
- Patients with systemic diseases
- Pregnant or breastfeeding patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry, Department of Endodontics
Istanbul, Istanbul, 34854
About this study
Official title: The Effect of Apical Preperation Size on the Success of Regenerative Endodontic Treatment in Mature Teeth With Apical Periodontitis: A Randomized Clinical Trial
The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Regenerative endodontic treatment is a procedure that aims to eliminate infection and support healing of the tissues around the root of the tooth.
The main questions the study aims to answer are:
Read more
- Does a larger apical preparation improve healing around the root tip?
- Does apical preparation size affect pain after treatment or recovery of tooth vitality?
Researchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.
Participants:
- Received regenerative endodontic treatment with one of two apical preparation sizes
- Attended follow-up visits for clinical examination and radiographic evaluation
- Were monitored for pain and healing outcomes during the follow-up period
- Being tested
- Regenerative Endodontic Treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic TreatmentProcedure or surgery
Regenerative endodontic treatment (RET) is a biologically based procedure that includes root canal disinfection followed by placement of a biological scaffold to support tissue regeneration and periapical healing. In this study, the intervention differs according to the apical preparation size used (ISO 40 and ISO 80) in mature teeth with apical periodontitis.
| Study group | Role | What they receive |
|---|---|---|
| MAF 40 group | Experimental | Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 40. Receives: Procedure: Regenerative Endodontic Treatment |
| MAF 80 group | Experimental | Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 80. Receives: Procedure: Regenerative Endodontic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primer success
Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion.
Measured: 6 months and 12 months
Secondary success
Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations.
Measured: 6 months and 12 months
Secondary outcomes (4)
Postoperative Pain
Postoperative pain was evaluated using a visual analogue scale.
Measured: baseline, day 1, day 2, and day 7 after treatment
Periapical Lesion Area
Changes in the periapical lesion area were measured using digital radiographic analysis.
Measured: Baseline, 6 months, 12 months
Mean Gray Value
Bone density changes in the periapical region were evaluated using mean gray value measurements obtained from digital radiographs.
Measured: Baseline, 6 months, 12 months
Fractal Dimension
Changes in trabecular bone microarchitecture in the periapical region were evaluated using fractal dimension analysis.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start29 Jul 2024
- Primary completion23 Oct 2025
- Study completion23 Oct 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 Marmara UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466433
- Sponsor's protocol ID
- 2024/13/877
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 12 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Apical Preperation Size on the Success of Regenerative Endodontic Treatment in Mature Teeth With Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07466433
- Acronym / sponsor ID
- 2024/13/877
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 12 Mar 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.
The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Regenerative endodontic treatment is a procedure that aims to eliminate infection and support healing of the tissues around the root of the tooth.
The main questions the study aims to answer are:
- Does a larger apical preparation improve healing around the root tip?
- Does apical preparation size affect pain after treatment or recovery of tooth vitality?
Researchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.
Participants:
- Received regenerative endodontic treatment with one of two apical preparation sizes
- Attended follow-up visits for clinical examination and radiographic evaluation
- Were monitored for pain and healing outcomes during the follow-up 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 |
|---|---|---|
| MAF 40 group | Experimental | Procedure: Regenerative Endodontic TreatmentParticipants receive regenerative endodontic treatment with apical preparation completed to ISO size 40. |
| MAF 80 group | Experimental | Procedure: Regenerative Endodontic TreatmentParticipants receive regenerative endodontic treatment with apical preparation completed to ISO size 80. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Single-rooted mature teeth with periapical lesions
- Teeth with a PAI score ≥ 3
- Patients aged 18-45 years
- Systemically healthy individuals
- Patients who provided written informed consent
Key exclusion criteria (9 listed)
- Immature teeth
- Previously root canal treated teeth
- Teeth with a PAI score <3
- Developmental anomalies
- Advanced periodontal destruction
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 |
|---|---|---|
| Regenerative Endodontic TreatmentRegenerative endodontic treatment (RET) is a biologically based procedure that includes root canal disinfection followed by placement of a biological scaffold to support tissue regeneration and periapical healing. In this study, the intervention differs according to the apical preparation size used (ISO 40 and ISO 80) in mature teeth with apical periodontitis. | Procedure or surgery | MAF 40 group, MAF 80 group |
Primary outcome
Primer success
Time frame: 6 months and 12 months
Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion.
Secondary success
Time frame: 6 months and 12 months
Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations.
4 secondary outcomes
Postoperative Pain
Time frame: baseline, day 1, day 2, and day 7 after treatment
Periapical Lesion Area
Time frame: Baseline, 6 months, 12 months
Mean Gray Value
Time frame: Baseline, 6 months, 12 months
Fractal Dimension
Time frame: Baseline, 6 months, 12 months
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 12 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. 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 Regenerative Endodontic Treatment in people with Apical Periodontitis and Mature Teeth, run by Marmara 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 5 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 12 Mar 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?
Primer success (time frame: 6 months and 12 months). The study lists 2 primary outcomes in all. 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 12 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.