Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander

NCT03153995 | Completed

• 1 other identifier: FDASU-REC per-16-3
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study will be to assess and compare between sub-periosteal self- inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge augmentation and periosteal releasing incision using autogenous onlay block bone graft. The assessment and comparison will be based on:

1. 1.Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar
2. 2.Quantity of the soft tissue obtained after soft tissue expansion.

Conditions

Horizontal Ridge Deficiency

Keywords

expander

Outcome Measures

Primary Outcomes (1)

• Change in ridge dimensional alteration by CBCT

  The ridge width will be compared between the two treatment groups by CBCT

  baseline, 6 months after surgery, 3 months after implant surgery

Secondary Outcomes (1)

• Soft tissue volume gain

  baseline, 4 weeks

Study Arms (2)

sub-periosteal soft tissue expansion

EXPERIMENTAL

Eight patients will receive osmotic hydrogel expanders prior to bone augmentation procedures. All expanders will be placed in sub-periosteal positions using the tunnel technique.

Procedure: soft tissue expansion

periosteal releasing incision

ACTIVE COMPARATOR

periosteal releasing incision will be performed for Eight patients during ridge augmentation surgery .

Procedure: soft tissue expansion

Interventions

soft tissue expansion PROCEDURE

Three surgeries will be carried out for group I patients: * Soft tissue expansion (1st surgery); at baseline * Alveolar ridge augmentation (2nd surgery); after five weeks * Implant surgery (3rd surgery); after six months

Also known as: osmed

periosteal releasing incision; sub-periosteal soft tissue expansion

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients should have partially edentulous ridge (missing upper one or two neighboring anterior teeth or premolars) of the maxilla. The edentulous area should require horizontal bone augmentation procedures owing to lack of sufficient residual bone.
• All patients should not have any particular medical history (medically free) according to Burket health medical history questionnaire (Glick et al.2008).
• All patients should not have any known contraindication to oral surgery.

You may not qualify if:

• Smokers will be excluded from our study.
• Patients with poor oral hygiene or not willing to perform oral hygiene measures.
• Patients who showed residual infections in the edentulous area or apparent infection in a neighboring tooth.
• Patients with systemic diseases such as diabetes mellitus and hemorrhagic disorders, patients receiving intravenous bisphosphonate therapy or systemic corticosteroid treatment.
• Patients with occlusal discrepancies will be excluded.
• Vulnerable groups (as pregnant and lactating females, and decisionaly impaired individuals) will be excluded from the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry Ain Shams university

Cairo, Cairo Governorate, 11553, Egypt

Location

Study Officials

• Ahmed Amr, lecturer

  Ainshams University

  STUDY DIRECTOR

• Nevine Kheir eldin, professor

  Ainshams University

  STUDY DIRECTOR

• Ehab Abd elhamid, professor

  Ainshams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 15, 2017
• Study Start: November 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)