Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement

NCT04415619 | Unknown

• 1 other identifier: Buccal pad of fat free tissue
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant. Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.

Conditions

Dental Implant

Keywords

Implant; Buccal fat pad; Immediate

Outcome Measures

Primary Outcomes (5)

• Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.

  Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using: a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain).

  6 months

• Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.

  Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)

  6 months

• Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.

  Evaluation of soft tissue healing At week 1, week4 and at 6 months: Presence/absence of postoperative complications will be evaluated, including: Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation.

  6 months

• Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area

  Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.

  6 months

• Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.

  After 3 months then at 6 months Cone Beam CT will be requested in order to measure: * Bone density. * Amount of bone buccally and palatally to the implant. * Marginal bone loss.

  6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

10 patients will have immediate implant placement with buccal pad of fat free tissue

Procedure: Xenograft bone substitute (Osteo-biol)

Interventions

Xenograft bone substitute (Osteo-biol) PROCEDURE

Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.

Also known as: Implant(Superline®,DentiumCoTM), Osstell(ISQ®)

Intervention group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age between 20-45 years with no gender predilection.
• Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
• Patients with good oral hygiene.
• Bony defects more than 2 mm during implant placement treated by bone substitute.
• Patients fully capable to comply with the study protocol.

You may not qualify if:

• Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
• Heavy smokers (more than 20 cigarettes per day).
• Sites with acute oral infection.
• Pregnant and lactating patients.
• Untreated periodontal disease.
• Previous chemotherapy or irradiation of the head and neck.
• Inadequate interocclusal space.

Sponsors & Collaborators

• Alexandria University: lead

Related Publications (1)

• Penarrocha-Diago M, Alonso-Gonzalez R, Aloy-Prosper A, Penarrocha-Oltra D, Camacho F, Penarrocha-Diago M. Use of buccal fat pad to repair post-extraction peri-implant bone defects in the posterior maxilla. A preliminary prospective study. Med Oral Patol Oral Cir Bucal. 2015 Nov 1;20(6):e699-706. doi: 10.4317/medoral.20212.

  PMID: 26241450 BACKGROUND

Study Officials

• Lobna Elwan, BSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Nagy El Prince, PhD

  Alexandria University

  STUDY DIRECTOR

• Ahmed O. Swedan, PhD

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Dina Y. Attia, MSc

CONTACT

+01017510444; dina.youssef29@gmail.com

Lobna Elwan, BSc

CONTACT

lobnaelwan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: A group of 10 patients will receive immediate implant placement with buccal pad of fat coverage

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2020
• Primary Completion: October 13, 2020
• Study Completion: November 20, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06