Apicomarginal DefectsNCT05171543
Effect of Combined Use of an Allograft and Membrane on the Healing Outcome of Apicomarginal Defects
A study testing Periapical surgery with placement of an allograft and a membrane in people with Apicomarginal Defects, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Healing of apicomarginal defects using 2 different groups, one being treated with the use of an allograft and a membrane and a control group, will be assessed and compared using 2D and 3D criteria. Also,quality of life will be compared between the two groups. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Apicomarginal Defects
- What is being tested?
- Periapical surgery with placement of an allograft and a membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2021to 1 May 2022
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Age 16 years and older consenting to the surgical procedure as well as agreeing to preoperative and at least 1 follow-up CBCT evaluation after 12 months 2. Noncontributory medical history (American Society of Anesthesiologists class I and II) 3. Patients with a deep narrow pocket with probing depth >6 mm confined to buccal aspect of the root, 4. Negative response to vitality tests, 5. Radiographic evidence of radiolucency, 6. Failed previous root canal treatment and retreatment at least 1 year previously, 7. Previous surgery with unresolved bony lesion, 8. Recurrent episodes of purulent discharge, and 9. Adequate final restoration with no clinical evidence of coronal leakage.
Who cannot join
- 1. Patients with medical history with American Society of Anesthesiologists class III to V or Any systemic disease contraindicating oral surgical procedures, potentially affecting the healing process.
- 2. Chronic generalized periodontitis, 3. Evidence of root fracture, 4. resorptive processes involving more than apical third of the root
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Sanjay Tewari
Rohtak, Haryana, 124001
Sanjay Tewari, 9416259534, principalpgids@yahoo.in
About this study
Official title: Effect of Combined Use of an Allograft and a Membrane on the Healing Outcome of Apicomarginal Defects Using 2D and 3D Evaluation
Healing of apicomarginal defects using 2 different groups, one being treated with the use of an allograft and a membrane and a control group, will be assessed and compared using 2D and 3D criteria. Also,quality of life will be compared between the two groups.
Read the detailed description
Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region.
Various resorbable and non resorbable collagen membrane with or without xenograft, allograft and alloplastic materials have been used in different studies. Although animal studies have reported high success rates with the use of bone graft materials and membranes over the controls but no human study till date has evaluated or compared the effect of using an allograft and membrane versus Control.
Thus, the aim of the present study is to investigate to two hypothesis. The first null hypothesis stated that there would be no difference between quality of life and healing outcome of periapical defects with periodontal communications following surgery using membrane with allograft and the conventional control group utilizing no GTR technique. The second null hypothesis stated that there would be no difference in outcome derived from the assessment of 2D periapical radiographs and 3D CBCT imaging.
- Conditions
- Apicomarginal Defects
- Being tested
- Periapical surgery with placement of an allograft and a membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical surgery with placement of an allograft and a membraneProcedure or surgery
Periapical surgery will be done followed by placement of an allograft into the defect and a membrane over the defect before closure of the flap.
| Study group | Role | What they receive |
|---|---|---|
| Periapical surgery with placement of an allograft and a membrane | Experimental | Patients will undergo periapical surgery and an allograft and a membrane will be placed inside the bony crypt and over the denuded root surface respectively before closure of the flap. Receives: Procedure: Periapical surgery with placement of an allograft and a membrane |
| Periapical surgery with no placement of any graft or membrane | No intervention | Patients will undergo periapical surgery with no placement of any graft or membrane in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of apicomarginal defects.
Patients will be checked clinically for absence of signs and symptoms. Radiographic 2D assessment will be done by Rud and Molven criteria as follows:-
Complete healing- defined by re-establishment of the lamina dura Incomplete healing (scar tissue) Uncertain healing Unsatisfactory healing (failure). 3D healing will be assessed by modified PENN 3D criteria(Schloss et al) as-
Complete healing Limited healing Uncertain healing Unsatisfactory healing.
Measured: Baseline to 12 months
Secondary outcomes (1)
Assessment of quality of life
All patients will be given a questionnaire (Igor Tsesis et al) with 15 questions to evaluate their quality of life for 7 days postsurgery.
Measured: Baseline to day 7 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Feb 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT05171543
- Sponsor's protocol ID
- Rahul Sharma
- Status last verified
- May 2021
- First submitted
- 10 Dec 2021
- Last updated
- 29 Dec 2021
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Use of an Allograft and a Membrane on the Healing Outcome of Apicomarginal Defects Using 2D and 3D Evaluation
- ClinicalTrials.gov ID
- NCT05171543
- Acronym / sponsor ID
- Rahul Sharma
- Conditions
- Apicomarginal Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 29 Dec 2021 (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.
Healing of apicomarginal defects using 2 different groups, one being treated with the use of an allograft and a membrane and a control group, will be assessed and compared using 2D and 3D criteria. Also,quality of life will be compared between the two groups.
Detailed description
Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region.
Various resorbable and non resorbable collagen membrane with or without xenograft, allograft and alloplastic materials have been used in different studies. Although animal studies have reported high success rates with the use of bone graft materials and membranes over the controls but no human study till date has evaluated or compared the effect of using an allograft and membrane versus Control.
Thus, the aim of the present study is to investigate to two hypothesis. The first null hypothesis stated that there would be no difference between quality of life and healing outcome of periapical defects with periodontal communications following surgery using membrane with allograft and the conventional control group utilizing no GTR technique. The second null hypothesis stated that there would be no difference in outcome derived from the assessment of 2D periapical radiographs and 3D CBCT imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periapical surgery with placement of an allograft and a membrane | Experimental | Procedure: Periapical surgery with placement of an allograft and a membranePatients will undergo periapical surgery and an allograft and a membrane will be placed inside the bony crypt and over the denuded root surface respectively before closure of the flap. |
| Periapical surgery with no placement of any graft or membrane | No intervention | –Patients will undergo periapical surgery with no placement of any graft or membrane in the control group. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Age 16 years and older consenting to the surgical procedure as well as agreeing to preoperative and at least 1 follow-up CBCT evaluation after 12 months 2. Noncontributory medical history (American Society of Anesthesiologists class I and II) 3. Patients with a deep narrow pocket with probing depth >6 mm confined to buccal aspect of the root, 4. Negative response to vitality tests, 5. Radiographic evidence of radiolucency, 6. Failed previous root canal treatment and retreatment at least 1 year previously, 7. Previous surgery with unresolved bony lesion, 8. Recurrent episodes of purulent discharge, and 9. Adequate final restoration with no clinical evidence of coronal leakage.
Key exclusion criteria (2 listed)
- 1. Patients with medical history with American Society of Anesthesiologists class III to V or Any systemic disease contraindicating oral surgical procedures, potentially affecting the healing process.
- 2. Chronic generalized periodontitis, 3. Evidence of root fracture, 4. resorptive processes involving more than apical third of the root
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 |
|---|---|---|
| Periapical surgery with placement of an allograft and a membranePeriapical surgery will be done followed by placement of an allograft into the defect and a membrane over the defect before closure of the flap. | Procedure or surgery | Periapical surgery with placement of an allograft and a membrane |
Primary outcome
Healing of apicomarginal defects.
Time frame: Baseline to 12 months
Patients will be checked clinically for absence of signs and symptoms. Radiographic 2D assessment will be done by Rud and Molven criteria as follows:- Complete healing- defined by re-establishment of the lamina dura Incomplete healing (scar tissue) Uncertain healing Unsatisfactory healing (failure). 3D healing will be assessed by modified PENN 3D criteria(Schloss et al) as- Complete healing Limited healing Uncertain healing Unsatisfactory healing.
1 secondary outcome
Assessment of quality of life
Time frame: Baseline to day 7 postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periapical surgery with placement of an allograft and a membrane 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of apicomarginal defects. (time frame: Baseline 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 29 Dec 2021.