Apico Marginal DefectsNCT04396743
Comparative Evaluation of Two PRF Formulations on Quality of Life and Healing of Apicomarginal Defects
A study testing Periapical surgery with use of prf-high clot and membrane and Periapical surgery with use of prf-medium clot and membrane in people with Apico Marginal Defects, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Healing of apicomarginal defects using 2 different formulations of PRF i.e PRF -high and PRF-medium will be assessed and compared using 2D and 3D criteria. Also, in vitro evaluation of the PRF formulations and 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
- Apico Marginal Defects
- What is being tested?
- Periapical surgery with use of prf-high clot and membrane and Periapical surgery with use of prf-medium clot and membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 11 Dec 2019to 11 Apr 2021
- 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
- Patients of age 16 years and above.
- 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.
- periapical defect with periodontal communication.
- Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
- Negative response to vitality test.
- failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
Who cannot join
- Presence of buccal bone on flap elevation.
- Unrestorable tooth.
- fractured /perforated roots.
- smokers.
- pregnant females and lactating mothers
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: Comparative Evaluation of Two PRF Formulations on Quality of Life and 2D and 3D Assessment of Healing Outcome of Apicomarginal Defects.
Healing of apicomarginal defects using 2 different formulations of PRF i.e PRF -high and PRF-medium will be assessed and compared using 2D and 3D criteria. Also, in vitro evaluation of the PRF formulations and 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.
Recently, autologous platelet concentrates have been used instead of the conventional practice of using GTR barrier membranes for treating apicomarginal defects. Till date no human study has compared platelet formulations; PRF-high ( 2700 rpm for 12minutes) and PRF-medium (1500 rpm for 14minutes) to see any difference in the bony healing and the quality of life between the two groups and no study have assessed bony healing of the periapical defect with periodontal communication with the use of CBCT.
Thus, the aim of the present study is to investigate the effect of 2 different formulations of PRF on quality of life and healing outcome of periapical defects with periodontal communications . Also, in vitro histological and immunohistochemical evaluation and comparison of the clots prepared from different centrifugation protocols will be done .
- Conditions
- Apico Marginal Defects
- Being tested
- Periapical surgery with use of prf-high clot and membrane, Periapical surgery with use of prf-medium clot and membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical surgery with use of prf-high clot and membraneProcedure or surgery
Periapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap.
Periapical surgery with use of prf-medium clot and membraneProcedure or surgery
Periapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap.
| Study group | Role | What they receive |
|---|---|---|
| Periapical surgery with placement of prf high clots | Active comparator | Patients will undergo periapical surgery and PRF-high clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap. Receives: Procedure: Periapical surgery with use of prf-high clot and membrane |
| Periapical surgery with placement of prf medium clots | Active comparator | Patients will undergo periapical surgery and PRF-medium clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap. Receives: Procedure: Periapical surgery with use of prf-medium clot and membrane |
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 posted21 May 2020
- Study start11 Dec 2019
- Primary completion11 Apr 2021 (estimated)
- Study completion11 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apico Marginal 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
- 32 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
- NCT04396743
- Sponsor's protocol ID
- vidhiendo
- Status last verified
- Dec 2019
- First submitted
- 21 Apr 2020
- Last updated
- 21 May 2020
- 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Two PRF Formulations on Quality of Life and 2D and 3D Assessment of Healing Outcome of Apicomarginal Defects.
- ClinicalTrials.gov ID
- NCT04396743
- Acronym / sponsor ID
- vidhiendo
- Conditions
- Apico Marginal Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 11 Apr 2021 (estimated)
- Study completion
- 11 Apr 2021 (estimated)
- First posted
- 21 May 2020 (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 formulations of PRF i.e PRF -high and PRF-medium will be assessed and compared using 2D and 3D criteria. Also, in vitro evaluation of the PRF formulations and 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.
Recently, autologous platelet concentrates have been used instead of the conventional practice of using GTR barrier membranes for treating apicomarginal defects. Till date no human study has compared platelet formulations; PRF-high ( 2700 rpm for 12minutes) and PRF-medium (1500 rpm for 14minutes) to see any difference in the bony healing and the quality of life between the two groups and no study have assessed bony healing of the periapical defect with periodontal communication with the use of CBCT.
Thus, the aim of the present study is to investigate the effect of 2 different formulations of PRF on quality of life and healing outcome of periapical defects with periodontal communications . Also, in vitro histological and immunohistochemical evaluation and comparison of the clots prepared from different centrifugation protocols will be done .
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 prf high clots | Active comparator | Procedure: Periapical surgery with use of prf-high clot and membranePatients will undergo periapical surgery and PRF-high clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap. |
| Periapical surgery with placement of prf medium clots | Active comparator | Procedure: Periapical surgery with use of prf-medium clot and membranePatients will undergo periapical surgery and PRF-medium clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients of age 16 years and above.
- 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.
- periapical defect with periodontal communication.
- Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
- Negative response to vitality test.
Key exclusion criteria (5 listed)
- Presence of buccal bone on flap elevation.
- Unrestorable tooth.
- fractured /perforated roots.
- smokers.
- pregnant females and lactating mothers
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 use of prf-high clot and membranePeriapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap. | Procedure or surgery | Periapical surgery with placement of prf high clots |
| Periapical surgery with use of prf-medium clot and membranePeriapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap. | Procedure or surgery | Periapical surgery with placement of prf medium clots |
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:- 1. Complete healing- defined by re-establishment of the lamina dura 2. Incomplete healing (scar tissue) 3. Uncertain healing 4. Unsatisfactory healing (failure). 3D healing will be assessed by modified PENN 3D criteria(Schloss et al) as- 1. Complete healing 2. Limited healing 3. Uncertain healing 4. 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 21 May 2020.
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 use of prf-high clot and membrane and Periapical surgery with use of prf-medium clot and membrane in people with Apico Marginal 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 6 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: status not confirmed, as of the sponsor's last update on 21 May 2020. 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 21 May 2020.