Apicomarginal DefectsNCT07048171
TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS
A study testing Endodontic Micro-Surgery in people with Apicomarginal Defects, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To determine the effect of allograft and iPRF with or without collagen membrane on healing of apicomarginal defects : A Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apicomarginal Defects
- What is being tested?
- Endodontic Micro-Surgery
- 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
- 18 Apr 2025to 18 Apr 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's).
- Patients aged 18 years and above, presenting with chronic suppurative apical periodontitis in at least one tooth,
- Radiographic evidence of apical radiolucency with periodontal pocket depth exceeding 6 mm confined to buccal aspect of the root.
- Repeated abscess discharge despite satisfactory root canal treatment. 5.Patients with apicomarginal defects showing a denuded buccal bone plate
- 6.Failed primary root canal treatment 7.Adequate final restoration with no clinical evidence of coronal leakage.
Who cannot join
- Clinical or radiographic evidence of root fracture.
- Resorptive processes involving more than apical third of the root.
- Chronic generalized periodontitis.
- Failed previous endodontic surgery or failed root canal re-treatment.
- Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy, any condition effecting rate of healing like smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
DR. Sanjay Tewari, MDS, 09416259534, principalpgids@gmail.com
Mareesha, PG student, 09728202108, mareeshasingh95@gmail.com
About this study
To determine the effect of allograft and iPRF with or without collagen membrane on healing of apicomarginal defects : A Randomized Controlled Trial
Read the detailed description
RATIONALE: - Apicomarginal defects are characterized by localized alveolar bone loss spanning the entire length of the root from the crestal alveolar bone to the apex of the tooth. These defects often present as a challenge in endodontic and periodontal therapy due to their extensive involvement of both the root apex and the periodontal tissues. .The use of guided tissue regeneration techniques has been proposed as an adjunct to endodontic surgery in order to promote bone healing Guided tissue regeneration (GTR) is a technique which prevent epithelial down growth, if the epithelial cells are excluded from a wound long enough for other cells types with regenerative potential to become established. Till date about 14 studies have been done on apicomarginal defects involving 12 on human and 2 on animal studies. Many studies have used either membrane alone , membrane and bone graft , only membrane or periosteal bone graft/ autologus platelet concentrate for promoting healing in such defects. .Both membrane ,graft as well as combination of membrane and graft may act a space maintainer to prevent epithelial migration .No study so far has compared three dimensional healing after endodontic surgery with adjunct use of graft with or without use of membrane in apicomarginal defects. Nevertheless there has been no study with the use of allograft and iPRF with collagen membrane versus allograft and iPRF in the healing of apicomarginal defects and quality of life assessment.
AIM To assess whether the application of allograft and iPRF with collagen membrane leads to improved healing outcomes and enhanced quality of life compared to the use of only allogafts and iPRF in patients of apicomarginal defects .
PRIMARY OBJECTIVE To evaluate the impact of application of allograft and iPRF with collagen membrane on buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). \& modified PENN 3D criteria.
SECONDARY OBJECTIVE To compare quality of life of patients after periapical surgery with use of allograft and iPRF with collagen membrane and allograft and iPRF without collagen membrane in cases of apicomarginal defects .
SETTING: -Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.
STUDY DESIGN: - A randomized controlled trial
TIME FRAME: - 12Months
- Conditions
- Apicomarginal Defects
- Being tested
- Endodontic Micro-Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic Micro-SurgeryProcedure or surgery
Surgery performed using bone graft(DFDBA) and iPRF with collagen membrane in test group and bone graft and iPRF without collagen membrane in control group
| Study group | Role | What they receive |
|---|---|---|
| patients with apicomarginal defects receiving bone graft and iPRF with collagen membrane | Experimental | surgery performed using DFDBA bone graft and iPRF with collagen membrane Receives: Procedure: Endodontic Micro-Surgery |
| patients with apicomarginal defects receiving bone graft and iPRF without collagen membrane | Active comparator | surgery performed using DFDBA bone graft and iPRF without collagen membrane Receives: Procedure: Endodontic Micro-Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical healing assessment
Periapical healing comparison in 2 groups with buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). \& modified PENN 3D criteria .
Measured: Base line to 12 months
Secondary outcomes (1)
Quality of life assessment
to assess pain, swelling, mouth opening and effect on daily activities of patient among test and control group using OHIP-14 questionnaire. Pain Assesment with Value 0 indicate no pain \& 100 indicate maximum pain.
Measured: Base line to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start18 Apr 2025
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2027 (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
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048171
- Sponsor's protocol ID
- Mareesha
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS
- ClinicalTrials.gov ID
- NCT07048171
- Acronym / sponsor ID
- Mareesha
- Conditions
- Apicomarginal Defects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 2 Jul 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.
To determine the effect of allograft and iPRF with or without collagen membrane on healing of apicomarginal defects : A Randomized Controlled Trial
Detailed description
RATIONALE: - Apicomarginal defects are characterized by localized alveolar bone loss spanning the entire length of the root from the crestal alveolar bone to the apex of the tooth. These defects often present as a challenge in endodontic and periodontal therapy due to their extensive involvement of both the root apex and the periodontal tissues. .The use of guided tissue regeneration techniques has been proposed as an adjunct to endodontic surgery in order to promote bone healing Guided tissue regeneration (GTR) is a technique which prevent epithelial down growth, if the epithelial cells are excluded from a wound long enough for other cells types with regenerative potential to become established. Till date about 14 studies have been done on apicomarginal defects involving 12 on human and 2 on animal studies. Many studies have used either membrane alone , membrane and bone graft , only membrane or periosteal bone graft/ autologus platelet concentrate for promoting healing in such defects. .Both membrane ,graft as well as combination of membrane and graft may act a space maintainer to prevent epithelial migration .No study so far has compared three dimensional healing after endodontic surgery with adjunct use of graft with or without use of membrane in apicomarginal defects. Nevertheless there has been no study with the use of allograft and iPRF with collagen membrane versus allograft and iPRF in the healing of apicomarginal defects and quality of life assessment.
AIM To assess whether the application of allograft and iPRF with collagen membrane leads to improved healing outcomes and enhanced quality of life compared to the use of only allogafts and iPRF in patients of apicomarginal defects .
PRIMARY OBJECTIVE To evaluate the impact of application of allograft and iPRF with collagen membrane on buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). \& modified PENN 3D criteria.
SECONDARY OBJECTIVE To compare quality of life of patients after periapical surgery with use of allograft and iPRF with collagen membrane and allograft and iPRF without collagen membrane in cases of apicomarginal defects .
SETTING: -Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.
STUDY DESIGN: - A randomized controlled trial
TIME FRAME: - 12Months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with apicomarginal defects receiving bone graft and iPRF with collagen membrane | Experimental | Procedure: Endodontic Micro-Surgerysurgery performed using DFDBA bone graft and iPRF with collagen membrane |
| patients with apicomarginal defects receiving bone graft and iPRF without collagen membrane | Active comparator | Procedure: Endodontic Micro-Surgerysurgery performed using DFDBA bone graft and iPRF without collagen membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's).
- Patients aged 18 years and above, presenting with chronic suppurative apical periodontitis in at least one tooth,
- Radiographic evidence of apical radiolucency with periodontal pocket depth exceeding 6 mm confined to buccal aspect of the root.
- Repeated abscess discharge despite satisfactory root canal treatment. 5.Patients with apicomarginal defects showing a denuded buccal bone plate
- 6.Failed primary root canal treatment 7.Adequate final restoration with no clinical evidence of coronal leakage.
Key exclusion criteria (5 listed)
- Clinical or radiographic evidence of root fracture.
- Resorptive processes involving more than apical third of the root.
- Chronic generalized periodontitis.
- Failed previous endodontic surgery or failed root canal re-treatment.
- Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy, any condition effecting rate of healing like smoking.
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 |
|---|---|---|
| Endodontic Micro-SurgerySurgery performed using bone graft(DFDBA) and iPRF with collagen membrane in test group and bone graft and iPRF without collagen membrane in control group | Procedure or surgery | patients with apicomarginal defects receiving bone graft and iPRF with collagen membrane, patients with apicomarginal defects receiving bone graft and iPRF without collagen membrane |
Primary outcome
Periapical healing assessment
Time frame: Base line to 12 months
Periapical healing comparison in 2 groups with buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). \& modified PENN 3D criteria .
1 secondary outcome
Quality of life assessment
Time frame: Base line to 12 months
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 2 Jul 2025.
Related trials for Apicomarginal Defects
Not yet recruiting
Healing of Apicomarginal Defects Using Autograft or Allograft With Collagen Membrane
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Micro-Surgery 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 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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. Sanjay Tewari, MDS (09416259534, tewarisanjayrohtak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical healing assessment (time frame: Base line to 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 2 Jul 2025.