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.

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03695549
• Other study ID #: assistant lecturer
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: heba samir mahmoud, assistant lecturer
• Phone: 01222541606
• Email: heba227[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• CAF + (A-PRF)
advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .
• CAF+SCTG
cornally advanced flap plus subepithilial connective tissue graft harvested from the palate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	root coverage	measured in millimeter	9 months
Secondary	Gingival esthetics	Root coverage esthetic score	9 months
Secondary	Recession width	measured in millimeter	9 months
Secondary	Clinical attachment level	measured in millimeter	9 months
Secondary	Width of keratinized gingiva	measured in millimeter	9 months
Secondary	Probing depth	measured in millimeter	9 months
Secondary	Gingival thickness	measured in millimeter	9 months
Secondary	Post-operative pain	Visual analog scale (VAS) Questionnaire	measured daily for the first 2 weeks post- operatively.
Secondary	Patient Satisfaction	Post-Surgical Patient Satisfaction Questionnaire	9 months
Secondary	Early wound healing	Early wound healing index	1,2,4 weeks post- surgical