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

Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area

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.

Study Overview

• Status: Unknown
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: Xenograft bone substitute (Osteo-biol)

Detailed Description

Ten patients will be selected randomly from the outpatient clinic, Alexandria University seeking for an immediate implant placement. The sample will be selected to match the inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth extraction, placement of an immediate implant, bone grafting material and autologous soft tissue graft from the buccal pad of fat. Patients will be assessed clinically and radiographically to evaluate bone and soft tissue measurements.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 10 patients will have immediate implant placement with buccal pad of fat free tissue	Procedure: Xenograft bone substitute (Osteo-biol); Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.; Other Names: Implant(Superline®,DentiumCoTM); Osstell(ISQ®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Lobna Elwan, BSc, Alexandria University; Study Director: Nagy El Prince, PhD, Alexandria University; Study Director: Ahmed O. Swedan, PhD, Alexandria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): October 13, 2020
• Study Completion (Anticipated): November 20, 2020

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Implant; Buccal fat pad; Immediate
• Other Study ID Numbers: Buccal pad of fat free tissue

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No