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Completed

NCT Number: NCT03153995

Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Ain Shams university

Cairo, Cairo Governorate, 11553, Egypt

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: osmed

Primary outcomes

  1. Change in ridge dimensional alteration by CBCT

    Time frame: baseline, 6 months after surgery, 3 months after implant surgery

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

Secondary outcomes

  1. Soft tissue volume gain

    Time frame: baseline, 4 weeks

    Soft tissue volume gain will be assessed by volumetric analysis

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 15, 2017
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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