Endodontic-Periodontal LesionsNCT07653997
The MTA Effect on Healing and Biomarkers in Endo-Perio Lesions
A study testing Root Canal Treatment with MTA Apical Plug, Root Canal Treatment with Resin-Based Sealer (AH Plus) and Periodontal Therapy (Scaling and Root Planing) in people with Endodontic-Periodontal Lesions and Apical Periodontitis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This project is a randomized controlled clinical study investigating the effect of Mineral Trioxide Aggregate (MTA) used as an apical plug in root canal obturation on periodontal healing and inflammatory biomarkers in teeth with combined endodontic-periodontal (endo-perio) lesions. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic-Periodontal Lesions, Apical Periodontitis, Periapical Disease
- What is being tested?
- Root Canal Treatment with MTA Apical Plug, Root Canal Treatment with Resin-Based Sealer (AH Plus) and Periodontal Therapy (Scaling and Root Planing)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 20 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
- Aged between 18 and 60 years Systemically healthy individuals Presence of radiographically confirmed periapical lesion Diagnosis of apical periodontitis and/or combined endodontic-periodontal lesion Ability to understand and sign informed consent Willingness to attend follow-up visits
Who cannot join
- Patients with severe systemic diseases (ASA III-VI) Teeth with advanced mobility (Miller Class III or higher) Patients unable to tolerate dental treatment procedures Patients unwilling to participate or attend follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
Istanbul
About this study
Official title: Effect of Root Canal Obturation With MTA on Periodontal Healing and Inflammatory Biomarkers in Combined Endo-Perio Lesions: A Randomized Controlled Clinical Trial
This project is a randomized controlled clinical study investigating the effect of Mineral Trioxide Aggregate (MTA) used as an apical plug in root canal obturation on periodontal healing and inflammatory biomarkers in teeth with combined endodontic-periodontal (endo-perio) lesions. The study compares MTA with resin-based sealers and evaluates clinical, radiographic, and biochemical outcomes, including levels of IL-10, TNF-α, and MMP-8 in gingival crevicular fluid. The ultimate goal is to determine which treatment approach improves healing and increases tooth survival in such complex lesions.
Read the detailed description
This study includes 120 patients, divided into three groups: healthy controls, patients with combined endo-perio lesions, and patients with apical periodontitis only. Standardized root canal treatment will be performed under aseptic conditions. Teeth will be obturated using either MTA apical plug or resin-based sealer (AH Plus) following mechanical preparation and irrigation protocols.
Clinical and radiographic healing will be assessed using periapical index (PAI) scores, and gingival crevicular fluid (GCF) samples will be collected at baseline and during follow-up (up to 1 year) to analyze inflammatory biomarkers (IL-10, TNF-α, MMP-8). Periodontal treatment will be performed when required in combined lesion cases.
Inclusion criteria include patients aged 18-60 years, systemically healthy individuals, presence of radiographic periapical lesions, ability to provide informed consent, and willingness to attend follow-up visits.
Exclusion criteria include patients with severe systemic diseases (ASA III-VI) and teeth with advanced mobility (Miller Class ≥3).
Statistical analyses (t-test, Mann-Whitney U, Pearson and Spearman correlations) will be used to compare groups and evaluate relationships between healing outcomes and biomarker levels. The study aims to determine whether MTA provides superior biological and clinical outcomes compared to conventional sealers and to improve treatment strategies and prognosis assessment in endo-perio lesions.
- Being tested
- Root Canal Treatment with MTA Apical Plug, Root Canal Treatment with Resin-Based Sealer (AH Plus), Periodontal Therapy (Scaling and Root Planing), Gingival Crevicular Fluid Sampling
- Keywords
- Endo-perio lesion, Root canal treatment, MTA, Periodontal healing, Gingival crevicular fluid
- Medical subject headings
- Periapical Periodontitis, Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal Treatment with MTA Apical PlugProcedure or surgery
Standardized root canal treatment performed under aseptic conditions. Following chemomechanical preparation, an apical plug is created using Mineral Trioxide Aggregate (MTA), and the remaining canal is obturated with resin-based sealer and gutta-percha.
Root Canal Treatment with Resin-Based Sealer (AH Plus)Procedure or surgery
Standardized root canal treatment performed under aseptic conditions. After chemomechanical preparation, the canal is obturated using gutta-percha in combination with an epoxy resin-based sealer (AH Plus).
Periodontal Therapy (Scaling and Root Planing)Procedure or surgery
Non-surgical periodontal treatment including scaling and root planing performed following endodontic treatment in patients diagnosed with combined endodontic-periodontal lesions.
Gingival Crevicular Fluid SamplingOther
Collection of gingival crevicular fluid samples at baseline and follow-up visits for the analysis of inflammatory biomarkers (IL-10, TNF-α, MMP-8) using ELISA.
| Study group | Role | What they receive |
|---|---|---|
| Endo-Perio + MTA | Experimental | Teeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy. Receives: Procedure: Root Canal Treatment with MTA Apical Plug; Procedure: Periodontal Therapy (Scaling and Root Planing); Other: Gingival Crevicular Fluid Sampling |
| Endo-Perio + Resin Sealer | Active comparator | Teeth with combined endo-perio lesions treated with resin-based root canal sealer (AH Plus). Receives: Procedure: Root Canal Treatment with Resin-Based Sealer (AH Plus); Procedure: Periodontal Therapy (Scaling and Root Planing); Other: Gingival Crevicular Fluid Sampling |
| AP + MTA | Experimental | Teeth with apical periodontitis treated with MTA apical plug. Receives: Procedure: Root Canal Treatment with MTA Apical Plug; Other: Gingival Crevicular Fluid Sampling |
| AP + Resin Sealer | Active comparator | Teeth with apical periodontitis treated with resin-based sealer (AH Plus). Receives: Procedure: Root Canal Treatment with Resin-Based Sealer (AH Plus); Other: Gingival Crevicular Fluid Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periapical Index (PAI) Score
Periapical healing will be evaluated using the Periapical Index (PAI) score on periapical radiographs obtained at baseline and 1 year after treatment.
Measured: Baseline and 1 year
Change in Probing Depth (PD)
Periodontal healing will be assessed by measuring probing depth (PD) in millimeters at baseline and 1 year after treatment.
Measured: Baseline and 1 year
Change in Clinical Attachment Level (CAL)
Periodontal healing will be assessed by measuring clinical attachment level (CAL) in millimeters at baseline and 1 year after treatment.
Measured: Baseline and 1 year
Secondary outcomes (3)
Change in TNF-α Concentration in Gingival Crevicular Fluid
TNF-α concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.
Measured: Baseline and 1 year
Change in IL-10 Concentration in Gingival Crevicular Fluid
IL-10 concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.
Measured: Baseline and 1 year
Change in MMP-8 Concentration in Gingival Crevicular Fluid
MMP-8 concentration will be quantified by ELISA in gingival crevicular fluid samples collected at baseline and 1 year after treatment.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start20 Mar 2024
- Primary completion10 Apr 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic-Periodontal LesionsStudies 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Erdem Hepşenoğlu, Istanbul Medipol University Hospital
- Investigators
- yelda erdem hepsenoglu, Assoc.Prof., Principal investigator, Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653997
- Sponsor's protocol ID
- 10840098-202.3.02-E.1144
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Root Canal Obturation With MTA on Periodontal Healing and Inflammatory Biomarkers in Combined Endo-Perio Lesions: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07653997
- Acronym / sponsor ID
- 10840098-202.3.02-E.1144
- Keywords
- Endo-perio lesion, Root canal treatment, MTA, Periodontal healing, Gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 17 Jun 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.
This project is a randomized controlled clinical study investigating the effect of Mineral Trioxide Aggregate (MTA) used as an apical plug in root canal obturation on periodontal healing and inflammatory biomarkers in teeth with combined endodontic-periodontal (endo-perio) lesions. The study compares MTA with resin-based sealers and evaluates clinical, radiographic, and biochemical outcomes, including levels of IL-10, TNF-α, and MMP-8 in gingival crevicular fluid. The ultimate goal is to determine which treatment approach improves healing and increases tooth survival in such complex lesions.
Detailed description
This study includes 120 patients, divided into three groups: healthy controls, patients with combined endo-perio lesions, and patients with apical periodontitis only. Standardized root canal treatment will be performed under aseptic conditions. Teeth will be obturated using either MTA apical plug or resin-based sealer (AH Plus) following mechanical preparation and irrigation protocols.
Clinical and radiographic healing will be assessed using periapical index (PAI) scores, and gingival crevicular fluid (GCF) samples will be collected at baseline and during follow-up (up to 1 year) to analyze inflammatory biomarkers (IL-10, TNF-α, MMP-8). Periodontal treatment will be performed when required in combined lesion cases.
Inclusion criteria include patients aged 18-60 years, systemically healthy individuals, presence of radiographic periapical lesions, ability to provide informed consent, and willingness to attend follow-up visits.
Exclusion criteria include patients with severe systemic diseases (ASA III-VI) and teeth with advanced mobility (Miller Class ≥3).
Statistical analyses (t-test, Mann-Whitney U, Pearson and Spearman correlations) will be used to compare groups and evaluate relationships between healing outcomes and biomarker levels. The study aims to determine whether MTA provides superior biological and clinical outcomes compared to conventional sealers and to improve treatment strategies and prognosis assessment in endo-perio lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Endo-Perio + MTA | Experimental | Procedure: Root Canal Treatment with MTA Apical Plug, Procedure: Periodontal Therapy (Scaling and Root Planing), Other: Gingival Crevicular Fluid SamplingTeeth with combined endodontic-periodontal lesions treated with MTA apical plug and root canal therapy. |
| Endo-Perio + Resin Sealer | Active comparator | Procedure: Root Canal Treatment with Resin-Based Sealer (AH Plus), Procedure: Periodontal Therapy (Scaling and Root Planing), Other: Gingival Crevicular Fluid SamplingTeeth with combined endo-perio lesions treated with resin-based root canal sealer (AH Plus). |
| AP + MTA | Experimental | Procedure: Root Canal Treatment with MTA Apical Plug, Other: Gingival Crevicular Fluid SamplingTeeth with apical periodontitis treated with MTA apical plug. |
| AP + Resin Sealer | Active comparator | Procedure: Root Canal Treatment with Resin-Based Sealer (AH Plus), Other: Gingival Crevicular Fluid SamplingTeeth with apical periodontitis treated with resin-based sealer (AH Plus). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 18 and 60 years Systemically healthy individuals Presence of radiographically confirmed periapical lesion Diagnosis of apical periodontitis and/or combined endodontic-periodontal lesion Ability to understand and sign informed consent Willingness to attend follow-up visits
Key exclusion criteria (1 listed)
- Patients with severe systemic diseases (ASA III-VI) Teeth with advanced mobility (Miller Class III or higher) Patients unable to tolerate dental treatment procedures Patients unwilling to participate or attend follow-up visits
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 Treatment with MTA Apical PlugStandardized root canal treatment performed under aseptic conditions. Following chemomechanical preparation, an apical plug is created using Mineral Trioxide Aggregate (MTA), and the remaining canal is obturated with resin-based sealer and gutta-percha. | Procedure or surgery | AP + MTA, Endo-Perio + MTA |
| Root Canal Treatment with Resin-Based Sealer (AH Plus)Standardized root canal treatment performed under aseptic conditions. After chemomechanical preparation, the canal is obturated using gutta-percha in combination with an epoxy resin-based sealer (AH Plus). | Procedure or surgery | AP + Resin Sealer, Endo-Perio + Resin Sealer |
| Periodontal Therapy (Scaling and Root Planing)Non-surgical periodontal treatment including scaling and root planing performed following endodontic treatment in patients diagnosed with combined endodontic-periodontal lesions. | Procedure or surgery | Endo-Perio + MTA, Endo-Perio + Resin Sealer |
| Gingival Crevicular Fluid SamplingCollection of gingival crevicular fluid samples at baseline and follow-up visits for the analysis of inflammatory biomarkers (IL-10, TNF-α, MMP-8) using ELISA. | Other | AP + MTA, AP + Resin Sealer, Endo-Perio + MTA, Endo-Perio + Resin Sealer |
Primary outcome
Change in Periapical Index (PAI) Score
Time frame: Baseline and 1 year
Periapical healing will be evaluated using the Periapical Index (PAI) score on periapical radiographs obtained at baseline and 1 year after treatment.
Change in Probing Depth (PD)
Time frame: Baseline and 1 year
Periodontal healing will be assessed by measuring probing depth (PD) in millimeters at baseline and 1 year after treatment.
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 1 year
Periodontal healing will be assessed by measuring clinical attachment level (CAL) in millimeters at baseline and 1 year after treatment.
3 secondary outcomes
Change in TNF-α Concentration in Gingival Crevicular Fluid
Time frame: Baseline and 1 year
Change in IL-10 Concentration in Gingival Crevicular Fluid
Time frame: Baseline and 1 year
Change in MMP-8 Concentration in Gingival Crevicular Fluid
Time frame: Baseline and 1 year
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 17 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request following publication of the primary study results.
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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.
yelda erdem hepsenoglu, Assoc.Prof. principal investigator
Istanbul Medipol University, Faculty of Dentistry, Department of Endodontics
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 Treatment with MTA Apical Plug, Root Canal Treatment with Resin-Based Sealer (AH Plus) and Periodontal Therapy (Scaling and Root Planing) in people with Endodontic-Periodontal Lesions and Apical Periodontitis, run by Istanbul Medipol University Hospital 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 1 inclusion and 1 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 17 Jun 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?
Change in Periapical Index (PAI) Score (time frame: Baseline and 1 year). The study lists 3 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 17 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.