Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession

NCT ID: NCT06621433

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-01-22

Brief Summary

The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Coronally advanced flap (CAF) in conjunction with titanium prepared PRF

Group Type: EXPERIMENTAL

T-PRF with CAF

Intervention Type: OTHER

Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.

CAF in conjunction with subepithelial connective tissue graft (SECTG)

Group Type: ACTIVE_COMPARATOR

SECTG with CAF

Intervention Type: OTHER

Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.

Interventions

T-PRF with CAF

Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.

Intervention Type: OTHER

SECTG with CAF

Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Gingival recession type 2 according to Cairo et al (2011).
• Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
• Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
• Clinically thick gingival biotype (1mm < gingival thickness).
• Anterior esthetic zone.

Exclusion Criteria

• Patients with gingival recession types 1 and 3 according to Cairo et al.
• Inadequate amount of attached gingiva (AG < 2 mm).
• Uncooperative patients.
• Smoking more than 10 cigarettes per day.
• Patients with known systemic conditions or taking medications that may affect soft tissue healing.
• Pregnant and lactating women.
• Patients with parafunctional habits.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rizk Beshir

OTHER

Sponsor Role: lead

Responsible Party

Rizk Beshir

MSc. candidate of periodontology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

1/1-2023

Identifier Type: -

Identifier Source: org_study_id