Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation

NCT05317039 | Unknown

• 1 other identifier: Piezosurgery_2021
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• change in alveolar ridge width

  All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.

  at baseline and 6 months

Study Arms (2)

Group A

EXPERIMENTAL

Group A will be treated with the buccal plate repositioning technique and grafted with SCPC.

Other: silica-calcium phosphate nanocomposite SCPC

Group B

ACTIVE COMPARATOR

Group B will be similarly managed and grafted using DFDBA

Other: freezed dried bone

Interventions

silica-calcium phosphate nanocomposite SCPC OTHER

Patients will be treated with the buccal plate repositioning technique and grafted with SCPC then the grafted defect will be covered with a platelet-rich fibrin membrane.

Group A

freezed dried bone OTHER

Patients will be treated with the buccal plate repositioning technique and grafted using DFDBA. then the grafted defect will be covered with a platelet-rich fibrin membrane.

Group B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
• Augmented area length in the mesial-distal direction of less than 20 mm.
• Adequate physically healthy condition.

You may not qualify if:

• A systemic disease that would contraindicate oral surgical treatment.
• Treated patients who had undergone therapy involving radiation
• Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
• Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

silica-calcium phosphate nanocomposite

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: August 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

EG (1)