Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft

Soft Tissue Mass Clinical Trial

Official title:

Evaluation of the Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03628170
• Other study ID #: version 3
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: February 2019

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: Haya Hesham, Masters
• Phone: 01272789994
• Email: shaimaanasr[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.

Description:

Extraction of the non restorable tooth, then socket preservation is applied in experimental group using platelet rich fibrin, while in comparative group free gingival graft is applied with socket preservation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age range 25-50 years.

• Non- restorable teeth indicated for extraction.

• Good oral hygiene.

• Intact facial and lingual plates of bone, without infection or pathosis.

• Adequate apiacl bone for primaru stability

Exclusion Criteria:

• Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.

• Presence of periodontal and/or periapical infection.

• Smokers.

• Non-compliant patients.

• Pregnancy or lactation in females.

• History of head and neck radiotherapy.

Related Conditions & MeSH terms

• Soft Tissue Mass

Intervention

Other:
• platelet rich fibrin
platelet rich fibrin will be prepared from patient's venous blood and inserted in the centrifuge at 2000 r.p.m. for 12 minutes Then, the Platelet rich fibrin plug will be placed in the socket after extraction for socket preservation covered by platelet rich fibrin membrane.
• Free gingival graft
Free gingival graft will be taken from the palate to cover the socket after extraction of the tooth for socket preservation.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and dental medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue profile change	Optical scanning by optical scanner at baseline to the preoperative cast of the related area, then optical scanning to postoperative cast of the surgical area after 6 months. Then, superimposition between the two scans of the casts will be performed to measure the difference or change in the amount of soft tissue profile measured in millimeters between baseline and at 6 months	6 months
Secondary	Crestal bone level change	measured by Cone beam computed tomography (CBCT) taking the neighboring teeth as reference points, with superimposition between readings at baseline and at 6 months.; Superimposition will identify the difference or change in crestal bone level measured in millimeters between baseline and at 6 months.	6 months