Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting

NCT06637982 | Not Yet Recruiting

• 1 other identifier: A0302024OS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.

Conditions

Ridge Splitting

Outcome Measures

Primary Outcomes (2)

• implant stability

  the stability of the implants will be evaluated by RFA with the Osstell Mentor device

  9 months

• alveolar ridge width

  alveolar ridge width will be measured preoperative, immediate postoperative and after 9 months

  9 months

Study Arms (2)

ridge splitting with allograft and pericardium membrane

EXPERIMENTAL

Procedure: ridge splitting with the use of allograft and pericardium membrane

ridge splitting with extended platelet rich fibrin

EXPERIMENTAL

Procedure: ridge splitting with the use of extended platelet rich fibrin

Interventions

ridge splitting with the use of allograft and pericardium membrane PROCEDURE

ridge splitting with the use of allograft and pericardium membrane

ridge splitting with allograft and pericardium membrane

ridge splitting with the use of extended platelet rich fibrin PROCEDURE

ridge splitting with the use of extended platelet rich fibrin

ridge splitting with extended platelet rich fibrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age 18 years old and older.
• Patient's cooperation, motivation and good oral hygiene.
• Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
• Absence of undercuts in buccal aspect of the ridge.
• Favorable occlusion and no parafunctional habits.
• Patients able to comply with the required recall visits.
• No gender preface in selection of the patients.
• Acceptable inter-arch space for the future prosthesis.

You may not qualify if:

• Any pathological condition at the site of surgery.
• Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
• Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
• Heavy smoking and alcoholism.
• Parafunctional habits such as bruxism and clenching.
• Signs of acute infection or pus discharge.
• Untreated periodontal disease or bad oral hygiene.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Mansoura, Egypt, Egypt

Location

Central Study Contacts

faisal alshammri

CONTACT

1555250898; fasialshammry@std.mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: October 10, 2024
• Primary Completion: April 10, 2025
• Study Completion: October 10, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

EG (1)