- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04224935
The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
The Effect of Leukocyte Platelet Rich Fibrin(L-PRF) Membrane in The Treatment of Localized Gingival Recession (Randomized Controlled Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.
Group 1(10 patients) :
Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues
Group 2 (Control group)(10 patients) :
Coronally repositioned flap will be done with sub epithelial connective tissue Parameters
- Clinical evaluation of percentage of root coverage and keratinized tissue width
- Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include
Both evaluations will be done at 3, 6 and 9 months
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Faculty of Dentistry Ain Shams University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Systemically free patients (American Society of Anesthesiologists I; ASA I).
- Age range (20 -40) years.
- Good compliance with the plaque control instructions following initial therapy.
- Patients diagnosed with Miller class I or II in anterior and premolar teeth
- Availability for follow up and maintenance program.
Exclusion Criteria:
- Patient suffering from periodontitis
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant and lactating females.
- Vulnerable group of patients (handicapped, mentally retarded and prisoners).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Leukocyte Platelet Rich Fibrin
Leukocyte Platelet Rich Fibrin will be used
|
the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
Other Names:
|
ACTIVE_COMPARATOR: connective tissue
connective tissue will be used
|
the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recession treatment
Time Frame: 9 months
|
2-Esthetic outcome evaluation was done using Root coverage esthetic score (RES) system ( Cairo et al. 2009) the RES include the following parameters • Level of the gingival margin (GM):(minimum) Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage;(maximum) 6 points = CRC. |
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
soft tissue thickness (Volumetric assessment)
Time Frame: 9 months
|
Preoperatively a cast was made and scanned.
At 9 months after surgical procedure the same procedure was done to determine the soft tissue thickness after the surgery.
The difference between the tissue thickness before and after was used to determine the efficacy of the different surgical grafting materials used.
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ahmed abdel aziz, co professor, Faculty of Dentistry Ain Shams University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
- 453
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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