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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04415619
• Other study ID #: Buccal pad of fat free tissue
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: Dina Y. Attia, MSc
• Phone: +01017510444
• Email: dina.youssef29[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 20, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant

Intervention

Procedure:
• Xenograft bone substitute (Osteo-biol)
Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

References & Publications (1)

Peñarrocha-Diago M, Alonso-González R, Aloy-Prósper A, Peñarrocha-Oltra D, Camacho F, Peñarrocha-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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