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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03153995
Enrollment
16
Registered
2017-05-15
Start date
2017-11-01
Completion date
2020-11-01
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horizontal Ridge Deficiency

Keywords

expander

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

Interventions

PROCEDUREsoft 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in ridge dimensional alteration by CBCTbaseline, 6 months after surgery, 3 months after implant surgeryThe ridge width will be compared between the two treatment groups by CBCT

Secondary

MeasureTime frameDescription
Soft tissue volume gainbaseline, 4 weeksSoft tissue volume gain will be assessed by volumetric analysis

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026