Apicomarginal DefectsNCT07412067
Healing of Apicomarginal Defects Using Autograft or Allograft With Collagen Membrane
A study testing Guided tissue regeneration in people with Apicomarginal Defects, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Apicomarginal defects, which connect apical and marginal bone loss, are difficult to manage surgically due to their limited regenerative potential. Guided tissue regeneration using grafts and collagen membranes may improve outcomes, but the comparative effectiveness of autografts and allografts in these defects is not… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apicomarginal Defects
- What is being tested?
- Guided tissue regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2026to 1 Dec 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
- Patients aged ≥18 years. Presence of chronic suppurative apical periodontitis with an apicomarginal defect and deep periodontal pocket, suggesting endodontic-periodontal communication up to the apex.
- Negative response to pulp vitality tests.
Who cannot join
- Presence of root fractures or perforations. Patients with compromised systemic health (ASA II or above). Smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shweta Mittal, MDS contact
India1 site
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak, Haryana, 124001
About this study
Official title: Comparative Evaluation of Autograft and Allograft With Collagen Membrane in the Healing of Apicomarginal Defects: A Parallel-Arm Randomized Clinical Trial
Apicomarginal defects, which connect apical and marginal bone loss, are difficult to manage surgically due to their limited regenerative potential. Guided tissue regeneration using grafts and collagen membranes may improve outcomes, but the comparative effectiveness of autografts and allografts in these defects is not well established. This randomized clinical trial at PGIDS Rohtak will evaluate 36 patients undergoing endodontic microsurgery, assigning them to either autograft or allograft combined with a bioresorbable collagen membrane. Clinical and CBCT-based radiographic healing will be monitored over 12 months. The study aims to determine whether allografts can achieve bone regeneration comparable to autografts, offering a less invasive option for treating apicomarginal defects.
Read the detailed description
Apicomarginal defects represent a challenging clinical scenario in endodontic surgery because they involve a continuous loss of both apical and marginal bone, which significantly reduces the chances of predictable regeneration. Conventional surgical approaches often yield limited success, prompting interest in guided tissue regeneration strategies that combine bone grafts with collagen membranes to enhance healing. Autografts remain the gold standard due to their inherent osteogenic potential, but their use is restricted by donor site morbidity, limited quantity, and increased operative time. Allografts provide a readily available and minimally invasive alternative, yet their performance in complex defects such as apicomarginal lesions has not been adequately compared to autografts.
This randomized clinical trial will be conducted at PGIDS Rohtak and will enroll 36 patients diagnosed with apicomarginal defects requiring endodontic microsurgery. Participants will be randomly allocated to one of two treatment groups: autograft with a bioresorbable collagen membrane or allograft with the same membrane configuration. Standardized microsurgical protocols will be followed for defect debridement, graft placement, and membrane adaptation. Postoperative evaluation will include clinical parameters such as periodontal attachment levels, probing depths, and symptom resolution, along with radiographic assessment using CBCT to quantify three-dimensional bone regeneration.
Follow-up examinations will be performed over a 12-month period to assess healing progression and compare outcomes between groups. The primary outcome measure will be volumetric bone fill evaluated through CBCT imaging, with secondary outcomes including clinical stability and the absence of disease recurrence. By directly comparing autografts and allografts under controlled conditions, this study aims to clarify whether allografts can provide equivalent regenerative outcomes, potentially offering clinicians a less invasive and more accessible option for managing apicomarginal defects in endodontic practice.
- Conditions
- Apicomarginal Defects
- Being tested
- Guided tissue regeneration
- Keywords
- apicomarginal, endodontic surgery, guided tissue regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided tissue regenerationProcedure or surgery
All participants will undergo standardized endodontic microsurgery to manage apicomarginal defects. After flap reflection, defect debridement, root-end preparation, and retrograde filling, patients will be randomly assigned to one of two groups.
Autograft + Collagen Membrane Group and Allograft + Collagen Membrane Group
| Study group | Role | What they receive |
|---|---|---|
| Apicomarginal defects treated with allograft and membrane combination | Experimental | Apicomarginal defects treated with allograft and membrane combination Receives: Procedure: Guided tissue regeneration |
| Apicomarginal defects treated with autograft and membrane combination | Active comparator | Apicomarginal defects treated with autograft and membrane combination Receives: Procedure: Guided tissue regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D and 3D Radiographic Healing
Volumetric bone fill in the apicomarginal defect, assessed using standardized CBCT imaging at baseline and 12 months. Bone regeneration will be quantified through CBCT-based volumetric analysis to compare healing between the autograft and allograft groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apicomarginal DefectsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Dental Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412067
- Sponsor's protocol ID
- Dr Jigyasa Duhan
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Autograft and Allograft With Collagen Membrane in the Healing of Apicomarginal Defects: A Parallel-Arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07412067
- Acronym / sponsor ID
- Dr Jigyasa Duhan
- Conditions
- Apicomarginal Defects
- Keywords
- apicomarginal, endodontic surgery, guided tissue regeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Dental Sciences
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Feb 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.
Apicomarginal defects, which connect apical and marginal bone loss, are difficult to manage surgically due to their limited regenerative potential. Guided tissue regeneration using grafts and collagen membranes may improve outcomes, but the comparative effectiveness of autografts and allografts in these defects is not well established. This randomized clinical trial at PGIDS Rohtak will evaluate 36 patients undergoing endodontic microsurgery, assigning them to either autograft or allograft combined with a bioresorbable collagen membrane. Clinical and CBCT-based radiographic healing will be monitored over 12 months. The study aims to determine whether allografts can achieve bone regeneration comparable to autografts, offering a less invasive option for treating apicomarginal defects.
Detailed description
Apicomarginal defects represent a challenging clinical scenario in endodontic surgery because they involve a continuous loss of both apical and marginal bone, which significantly reduces the chances of predictable regeneration. Conventional surgical approaches often yield limited success, prompting interest in guided tissue regeneration strategies that combine bone grafts with collagen membranes to enhance healing. Autografts remain the gold standard due to their inherent osteogenic potential, but their use is restricted by donor site morbidity, limited quantity, and increased operative time. Allografts provide a readily available and minimally invasive alternative, yet their performance in complex defects such as apicomarginal lesions has not been adequately compared to autografts.
This randomized clinical trial will be conducted at PGIDS Rohtak and will enroll 36 patients diagnosed with apicomarginal defects requiring endodontic microsurgery. Participants will be randomly allocated to one of two treatment groups: autograft with a bioresorbable collagen membrane or allograft with the same membrane configuration. Standardized microsurgical protocols will be followed for defect debridement, graft placement, and membrane adaptation. Postoperative evaluation will include clinical parameters such as periodontal attachment levels, probing depths, and symptom resolution, along with radiographic assessment using CBCT to quantify three-dimensional bone regeneration.
Follow-up examinations will be performed over a 12-month period to assess healing progression and compare outcomes between groups. The primary outcome measure will be volumetric bone fill evaluated through CBCT imaging, with secondary outcomes including clinical stability and the absence of disease recurrence. By directly comparing autografts and allografts under controlled conditions, this study aims to clarify whether allografts can provide equivalent regenerative outcomes, potentially offering clinicians a less invasive and more accessible option for managing apicomarginal defects in endodontic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apicomarginal defects treated with allograft and membrane combination | Experimental | Procedure: Guided tissue regenerationApicomarginal defects treated with allograft and membrane combination |
| Apicomarginal defects treated with autograft and membrane combination | Active comparator | Procedure: Guided tissue regenerationApicomarginal defects treated with autograft and membrane combination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥18 years. Presence of chronic suppurative apical periodontitis with an apicomarginal defect and deep periodontal pocket, suggesting endodontic-periodontal communication up to the apex.
- Negative response to pulp vitality tests.
Key exclusion criteria (1 listed)
- Presence of root fractures or perforations. Patients with compromised systemic health (ASA II or above). Smokers.
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 |
|---|---|---|
| Guided tissue regenerationAll participants will undergo standardized endodontic microsurgery to manage apicomarginal defects. After flap reflection, defect debridement, root-end preparation, and retrograde filling, patients will be randomly assigned to one of two groups. Autograft + Collagen Membrane Group and Allograft + Collagen Membrane Group | Procedure or surgery | Apicomarginal defects treated with allograft and membrane combination, Apicomarginal defects treated with autograft and membrane combination |
Primary outcome
2D and 3D Radiographic Healing
Time frame: 12 months
Volumetric bone fill in the apicomarginal defect, assessed using standardized CBCT imaging at baseline and 12 months. Bone regeneration will be quantified through CBCT-based volumetric analysis to compare healing between the autograft and allograft groups.
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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Apicomarginal Defects
Recruiting
TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS
Apicomarginal Defects
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.
Shweta Mittal, MDS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided tissue regeneration in people with Apicomarginal Defects, 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 2 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: opening soon, as of the sponsor's last update on 17 Feb 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 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.
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 Dr Jigyasa Duhan, MDS (+919896270449, prashitiduhan@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2D and 3D Radiographic Healing (time frame: 12 months). 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 Feb 2026.