Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander

Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander: A Randomized Controlled Clinical and Histological Study

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. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar

   ridge augmentation.

2. Quantity of the soft tissue obtained after soft tissue expansion.

Study Overview

• Status: Completed
• Conditions: Horizontal Ridge Deficiency
• Intervention / Treatment: Procedure: soft tissue expansion

Detailed Description

• Sixteen patients will be selected from the outpatient clinic of the department of, Oral medicine Periodontology, and oral diagnosis, Faculty of Dentistry, Ain Shams University.
• Three surgeries will be carried out for group I patient; the first is placement of soft tissue expander, the second surgery is bone grafting and placement of collagen membrane for ridge augmentation while the third (re-entry surgery) is implant placement in a routine fashion.

two surgeries will be carried out for group II patient; the first is surgery is bone grafting for ridge augmentation while the second (re-entry surgery) is implant placement in a routine fashion.

-Measurements and evaluation of edentulous ridge will be done by CBCT

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11553
      • Faculty of Dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sub-periosteal soft tissue expansion; 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; 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; Other Names: osmed
Active Comparator: periosteal releasing incision; periosteal releasing incision will be performed for Eight patients during ridge augmentation surgery .	Procedure: soft tissue expansion; 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; Other Names: osmed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue volume gain	Soft tissue volume gain will be assessed by volumetric analysis	baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed Amr, lecturer, Ainshams university; Study Director: Nevine Kheir eldin, professor, Ainshams university; Study Director: Ehab Abd elhamid, professor, Ainshams university

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: expander
• Other Study ID Numbers: FDASU-REC per-16-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No