Clinical trial NCT04415619: Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement
Official title: Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Keywords: Implant
Buccal fat pad
Immediate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A group of 10 patients will receive immediate implant placement with buccal pad of fat coverage
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alexandria University
name: Lobna Elwan, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Nagy El Prince, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Ahmed O. Swedan, PhD
role: STUDY_DIRECTOR
References:
citation: 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.