A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedMay 19, 2020
April 1, 2020
1.7 years
May 12, 2020
May 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to 12 Months
Secondary Outcomes (1)
Clinical success
Baseline to 12 Months
Study Arms (2)
Periapical surgery with PRF group
ACTIVE COMPARATORAutologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning.
Control group without PRF
PLACEBO COMPARATORFlap will be repositioned following apicoectomy without placement of any autologous platelet aggregate.
Interventions
PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
Flap will be repositioned following apicoectomy directly without placing any platelet aggregate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankita Ramani
Rohtak, Haryana, 124001, India
Study Officials
- PRINCIPAL INVESTIGATOR
ANKITA RAMANI
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 15, 2020
Study Start
July 1, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
May 19, 2020
Record last verified: 2020-04