- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04389346
A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates
A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ANKITA RAMANI
- Phone Number: 9582841539
- Email: ramaniankita95@gmail.com
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Recruiting
- Ankita Ramani
-
Contact:
- ANKITA RAMANI
- Phone Number: 9582841539
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Periapical surgery with PRF group
Autologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning.
|
PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
|
Placebo Comparator: Control group without PRF
Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate.
|
Flap will be repositioned following apicoectomy directly without placing any platelet aggregate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Baseline to 12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical success
Time Frame: Baseline to 12 Months
|
Clinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion
|
Baseline to 12 Months
|
Collaborators and Investigators
Investigators
- Principal Investigator: ANKITA RAMANI, Post graduate institute of dental sciences, Rohtak
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ankita Ramani
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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