Chronic Apical PeriodontitisNCT04389346
A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates
A study testing Periapical surgery using autologous platelet aggregate and Periapical surgery without autologous platelet aggregate in people with Chronic Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- Periapical surgery using autologous platelet aggregate and Periapical surgery without autologous platelet aggregate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2019to Mar 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures.
- Apicomarginal communication having probing depth > 6mm.
- Patients with no general medical contraindications for oral surgical procedures.
- Recurrent episodes of purulent discharge.
- Failed previous root canal treatment.
- Failed previous surgery with persistent bony lesion.
- 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.
- 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.
India1 site, 1 recruiting
- Recruiting
Ankita Ramani
Rohtak, Haryana, 124001
ANKITA RAMANI, 9582841539
About this study
Official title: A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial
This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.
Read the detailed description
Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- Periapical surgery using autologous platelet aggregate, Periapical surgery without autologous platelet aggregate
- Keywords
- Apicomarginal defects, Cone Beam Computed Tomography, Autologous platelet aggregate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical surgery using autologous platelet aggregateProcedure or surgery
PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
Periapical surgery without autologous platelet aggregateProcedure or surgery
Flap will be repositioned following apicoectomy directly without placing any platelet aggregate
| Study group | Role | What they receive |
|---|---|---|
| Periapical surgery with PRF group | Active comparator | Autologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning. Receives: Procedure: Periapical surgery using autologous platelet aggregate |
| Control group without PRF | Placebo comparator | Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate. Receives: Procedure: Periapical surgery without autologous platelet aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periapical radiolucency
2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 months by following scoring
scores for 2D healing
Score1-Complete healing defined by re-establishment of the lamina dura Score 2- Incomplete healing (scar tissue) Score 3- Uncertain healing Score 4- Unsatisfactory healing
scores for 3D healing Score1- Complete healing Score 2- Limited healing Score 3- Uncertain healing Score 4- Unsatisfactory healing
Measured: Baseline to 12 Months
Secondary outcomes (1)
Clinical success
Clinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion
Measured: Baseline 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 posted15 May 2020
- Study start1 Jul 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies 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
- Double blind
- Who is masked
- Participant, 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
- Investigators
- ANKITA RAMANI, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389346
- Sponsor's protocol ID
- Ankita Ramani
- Status last verified
- Apr 2020
- First submitted
- 12 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04389346
- Acronym / sponsor ID
- Ankita Ramani
- Conditions
- Chronic Apical Periodontitis
- Keywords
- Apicomarginal defects, Cone Beam Computed Tomography, Autologous platelet aggregate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 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.
This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.
Detailed description
Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periapical surgery with PRF group | Active comparator | Procedure: Periapical surgery using autologous platelet aggregateAutologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning. |
| Control group without PRF | Placebo comparator | Procedure: Periapical surgery without autologous platelet aggregateFlap will be repositioned following apicoectomy without placement of any autologous platelet aggregate. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures.
- Apicomarginal communication having probing depth > 6mm.
- Patients with no general medical contraindications for oral surgical procedures.
- Recurrent episodes of purulent discharge.
- Failed previous root canal treatment.
Key exclusion criteria (4 listed)
- Clinical or radiographic evidence of root fracture.
- Resorptive processes involving more than apical third of the root.
- 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 |
|---|---|---|
| Periapical surgery using autologous platelet aggregatePRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning | Procedure or surgery | Periapical surgery with PRF group |
| Periapical surgery without autologous platelet aggregateFlap will be repositioned following apicoectomy directly without placing any platelet aggregate | Procedure or surgery | Control group without PRF |
Primary outcome
Change in periapical radiolucency
Time frame: Baseline to 12 Months
2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 months by following scoring scores for 2D healing Score1-Complete healing defined by re-establishment of the lamina dura Score 2- Incomplete healing (scar tissue) Score 3- Uncertain healing Score 4- Unsatisfactory healing scores for 3D healing Score1- Complete healing Score 2- Limited healing Score 3- Uncertain healing Score 4- Unsatisfactory healing
1 secondary outcome
Clinical success
Time frame: Baseline to 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
ANKITA RAMANI principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
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 using autologous platelet aggregate and Periapical surgery without autologous platelet aggregate in people with Chronic Apical Periodontitis, 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 7 inclusion and 4 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 19 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. Some participants in this study may receive a placebo. 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?
Contact DR PANKAJ SANGWAN (9996112202, drps_1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in periapical radiolucency (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 19 May 2020.