Clinical trial NCT03695549: Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.
Official title: Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: advanced platelet rich fibrin,A-PRF
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results.

Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.

Detailed description: * Population (P): Patients with single Miller class I, II gingival recessions.
* Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF).
* Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG).
* Primary Outcome (O): Root coverage (mm).
* Time frame: 9 months.
* Study design: Randomized controlled clinical trial.
* Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients 18 years old and older both males and females.
* Good oral hygiene after phase I therapy.
* Miller's class I or II gingival recession.
* Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
* Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria:

* Pregnant or lactating females.
* Current Smokers.
* Patients with any systemic disease that may affect the periodontal healing.
* Teeth with endodontic treatment, buccal restoration or caries.
* Patients with poor oral hygiene

Primary outcomes:
measure: root coverage
timeFrame: 9 months
Secondary outcomes:
measure: Gingival esthetics
timeFrame: 9 months
measure: Recession width
timeFrame: 9 months
measure: Clinical attachment level
timeFrame: 9 months
measure: Width of keratinized gingiva
timeFrame: 9 months
measure: Probing depth
timeFrame: 9 months
measure: Gingival thickness
timeFrame: 9 months
measure: Post-operative pain
timeFrame: measured daily for the first 2 weeks post- operatively.
measure: Patient Satisfaction
timeFrame: 9 months
measure: Early wound healing
timeFrame: 1,2,4 weeks post- surgical
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Heba Samir Mhmoud, assistant lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Manal M Hosny, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Engi A Mahmoud, assistant professor
role: STUDY_CHAIR
References: