- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07662447
Clinical Evaluation of Platelet Rich Fibrin Membrane With or Without Hyaluronic Acid Along With Coronally Advanced Flap in the Treatment of Rt1 Gingival Recession
Gingival recession is a common mucogingival deformity that may result in root hypersensitivity, esthetic concern, plaque accumulation, and difficulty in oral hygiene maintenance. Modified coronally advanced flap procedures are widely used for Cairo RT1 gingival recession defects. Platelet-rich fibrin has been used as an autologous biologic adjunct, while hyaluronic acid has shown potential benefits in wound hydration, inflammation modulation, and soft tissue healing.
Aim: To evaluate the clinical effectiveness of multilayered platelet-rich fibrin with cross-linked hyaluronic acid compared with platelet-rich fibrin alone in the treatment of Cairo RT1 gingival recession defects using modified coronally advanced flap without vertical releasing incisions.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, United Arab Emirates, 00000
- Gulf Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Systemically healthy patients aged 18-50 years presenting with Cairo RT1 gingival recession defects were included in the study.
Patients were selected if the recession defect was present on a vital tooth with an identifiable cementoenamel junction and no interproximal clinical attachment loss.
The selected tooth was required to be free from caries, cervical restorations, non-carious cervical lesions interfering with measurement, pulpal pathology, and pathological mobility. Patients with acceptable oral hygiene after initial periodontal therapy, preferably with Plaque Index ≤1, were included.
Patients willing to participate in the study, sign informed consent, and report for all follow-up visits were included.
-Exclusion Criteria Patients were excluded if they were smokers or tobacco users, including smokeless tobacco users.
Patients with systemic conditions that could affect periodontal wound healing, such as uncontrolled diabetes mellitus, immunosuppressive disorders, bleeding disorders, connective tissue disorders, or any serious systemic illness, were not included. Pregnant or lactating women were excluded from the study.
Patients taking medications known to influence gingival healing, including corticosteroids, immunosuppressants, bisphosphonates, anticoagulants, or long-term anti-inflammatory drugs, were excluded. Patients with poor oral hygiene, untreated gingival inflammation, active periodontal disease, or recession defects classified as Cairo RT2 or RT3 were not included.
Teeth with cervical caries, cervical restorations, deep abrasion, erosion, non-carious cervical lesions interfering with CEJ identification, endodontic pathology, periapical lesions, non-vital pulp, traumatic occlusion that could not be corrected before surgery, or previous periodontal plastic surgery at the selected site within the past 12 months were excluded.
Patients undergoing orthodontic treatment or those who had recently completed orthodontic treatment were also excluded if tooth movement could affect gingival margin stability. Patients unwilling to provide consent or unable to attend the follow-up schedule were not included.
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: root coverage with multilayered PRF
|
root coverage with multilayered PRF
|
|
Experimental: root coverage with multilayered PRF and hyaluronic acid
|
root coverage with multilayered PRF and hyaluronic acid application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of root coverage
Time Frame: baseline, 3 months, 6 months
|
baseline, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain VAS score 1-10
Time Frame: baseline, 3 days, 3 weeks
|
VAS score 1-10
|
baseline, 3 days, 3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- NoorMDSperio
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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