- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07717398
Evaluation of The Effect of Injectable Platelet-rich Fibrin With Collagen Membrane in Miller Class II Gingival Recession Coverage
This study aims to evaluate the effect of injectable Platelet-Rich Fibrin (i-PRF) in combination with collagen membrane in the treatment of Miller Class II gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic concerns, root hypersensitivity, and increased risk of root caries.
The study will include patients diagnosed with Miller Class II gingival recession. Participants will be treated using a regenerative periodontal surgical approach involving coronally advanced flap combined with injectable platelet-rich fibrin and collagen membrane. Clinical parameters such as recession depth, clinical attachment level, and keratinized tissue width will be evaluated before and after treatment at specific follow-up intervals.
The objective is to compare the effectiveness of this combined regenerative approach in improving root coverage and soft tissue healing, and to assess its potential benefits in periodontal regeneration and esthetic outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Ramadan Shawky, MDS
- Phone Number: 201554497492
- Email: Ahmed7699staff@dent.tanta.edu.eg
Study Locations
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egypt
- Faculty of dentistry ,Tanta university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
Both males and females of age ≥ 18
Exclusion criteria:
History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that contraindicated periodontal surgical treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
i-PRF +collagen membrane
|
Application of injectable platelet -rich fibrin (I-PRF) in combination with a collagen membrane during the surgical procedure to enhance soft and hard tissue healing
Other Names:
|
|
Active Comparator: Group 2
CAF+SCTG
|
coronally advanced flap surgery combined with a subepithelial connective tissue graft for the treatment of gingival recession defects
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Keratinized Tissue Thickness
Time Frame: Baseline, 1 month ,3 months and 6 months after surgery
|
measured in millimeters (mm) using a endodontic file
|
Baseline, 1 month ,3 months and 6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recession Depth (RD)
Time Frame: baseline,1 month,3 months,6 months after surgery
|
baseline,1 month,3 months,6 months after surgery
|
|
Recession Width (RW)
Time Frame: Baseline,1 month,3 months ,and 6 months after surgery
|
Baseline,1 month,3 months ,and 6 months after surgery
|
|
keratinized Tissue Height (KTH)
Time Frame: Baseline, 1 month, 3 months, 6 months after surgery
|
Baseline, 1 month, 3 months, 6 months after surgery
|
|
Probing Pocket Depth (PPD)
Time Frame: Baseline and 6 months after surgery
|
Baseline and 6 months after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shereen Abdelmoula Ali, Faculty of dentistry ,Tanta university .Tanta, Eygpt
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- I_PRF with collagen membrane
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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