- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513222
Flipped Autograft for Treating Surgical Wound Dehiscence
Flipped Autograft: a Novel Approach for Management of Wound Dehiscence in Implant Dentistry
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ahmed hamdy, master degree
- Phone Number: +201061112512
- Email: ahmed.esmaail@bue.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11837
- Ahmed Hamdy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients in a healthy systemic condition.
- Both genders
- Patients should have single missing tooth.
- Seibert Class I ridge defect.
- Patients should approve to deliver a signature to a written consent after study nature explanation.
Exclusion Criteria:
1- Patients with any smoking habits. 2- Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.
3- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
4- Patients with infections either periodontally or periapically.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: flipped autograft
|
Thick lingual flap was de-epithelized and partially dissected to increase its length then flipped and sutured to the buccal flap to obtain primary closure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete primary intention healing of the wound dehiscence
Time Frame: 3 months
|
complete uneventful healing will be assessed clinically by measuring soft tissue width and thickness using periodontal probe under local anesthesia
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
esthetic outcome and patient satisfaction.
Time Frame: 3 months
|
esthetic outcome will be measured using pink esthetic score. Pink esthetic score (PES) will be recorded for five variables: "mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site". A score of 2, 1, or 0 will be assigned to all five parameters. also patient satisfaction will be recorded using: • (VAS) Visual analogue scale to measure postoperative pain. Pain score reported by the patient. directly through Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain) which will be recorded after 2 weeks (Yildirim et al., 2017) |
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hamdy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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