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.

NCT03695549 | Unknown DMC

• 1 other identifier: assistant lecturer
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Keywords

advanced platelet rich fibrin,A-PRF

Outcome Measures

Primary Outcomes (1)

• root coverage

  measured in millimeter

  9 months

Secondary Outcomes (9)

• Gingival esthetics

  9 months

• Recession width

  9 months

• Clinical attachment level

  9 months

• Width of keratinized gingiva

  9 months

• Probing depth

  9 months

Study Arms (2)

intervention

ACTIVE COMPARATOR

CAF+ APRF

Procedure: CAF + (A-PRF)

control

ACTIVE COMPARATOR

CAF+SCTG

Procedure: CAF+SCTG

Interventions

CAF + (A-PRF) PROCEDURE

advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .

intervention

CAF+SCTG PROCEDURE

cornally advanced flap plus subepithilial connective tissue graft harvested from the palate

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Heba Samir Mhmoud, assistant lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

• Manal M Hosny, professor

  Cairo University

  STUDY DIRECTOR

• Engi A Mahmoud, assistant professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

heba samir mahmoud, assistant lecturer

CONTACT

01222541606; heba227@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 4, 2018
• Study Start: October 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10