MedDataX Logo

Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander

NCT ID: NCT03153995

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Horizontal Ridge Deficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

expander

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

soft tissue expansion

Intervention Type 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

periosteal releasing incision

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

Group Type ACTIVE_COMPARATOR

soft tissue expansion

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

osmed

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alaa Talaat Ali

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Amr, lecturer

Role: STUDY_DIRECTOR

Ainshams University

Nevine Kheir eldin, professor

Role: STUDY_DIRECTOR

Ainshams University

Ehab Abd elhamid, professor

Role: STUDY_DIRECTOR

Ainshams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of dentistry Ain Shams university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FDASU-REC per-16-3

Identifier Type: -

Identifier Source: org_study_id