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Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03153995
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

  1. Quantity of the soft tissue obtained after soft tissue expansion.
Condition or Disease Intervention/Treatment Phase
  • Procedure: soft tissue expansion
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander: A Randomized Controlled Clinical and Histological Study
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in ridge dimensional alteration by CBCT [baseline, 6 months after surgery, 3 months after implant surgery]

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

    Secondary Outcome Measures

    1. Soft tissue volume gain [baseline, 4 weeks]

      Soft tissue volume gain will be assessed by volumetric analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of dentistry Ain Shams university Cairo Cairo Governorate Egypt 11553

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alaa Talaat Ali, assistant lecturer, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03153995
    Other Study ID Numbers:
    • FDASU-REC per-16-3
    First Posted:
    May 15, 2017
    Last Update Posted:
    Dec 1, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alaa Talaat Ali, assistant lecturer, Ain Shams University
    expander

    Study Results

    No Results Posted as of Dec 1, 2020