Flipped Autograft for Treating Surgical Wound Dehiscence
Primary Purpose
Wound Dehiscence
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
flipped autograft
Sponsored by
About this trial
This is an interventional treatment trial for Wound Dehiscence
Eligibility Criteria
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.
Sites / Locations
- Ahmed HamdyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
flipped autograft
Arm Description
Outcomes
Primary Outcome Measures
complete primary intention healing of the wound dehiscence
complete uneventful healing will be assessed clinically by measuring soft tissue width and thickness using periodontal probe under local anesthesia
Secondary Outcome Measures
esthetic outcome and patient satisfaction.
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)
Full Information
NCT ID
NCT05513222
First Posted
August 20, 2022
Last Updated
August 22, 2022
Sponsor
Ain Shams University
Collaborators
British University In Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05513222
Brief Title
Flipped Autograft for Treating Surgical Wound Dehiscence
Official Title
Flipped Autograft: a Novel Approach for Management of Wound Dehiscence in Implant Dentistry
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
January 29, 2024 (Anticipated)
Study Completion Date
May 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
British University In Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This case report describes a novel technique for management of peri-implant wound dehiscence that involves using auto graft from the same surgical site to seal the dehiscence defect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Dehiscence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
flipped autograft
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
flipped autograft
Intervention Description
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
Primary Outcome Measure Information:
Title
complete primary intention healing of the wound dehiscence
Description
complete uneventful healing will be assessed clinically by measuring soft tissue width and thickness using periodontal probe under local anesthesia
Time Frame
3 months
Secondary Outcome Measure Information:
Title
esthetic outcome and patient satisfaction.
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed hamdy, master degree
Phone
+201061112512
Email
ahmed.esmaail@bue.edu.eg
Facility Information:
Facility Name
Ahmed Hamdy
City
Cairo
ZIP/Postal Code
11837
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed hamdy, master degree
Phone
+201061112512
Email
ahmed.esmaail@bue.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Flipped Autograft for Treating Surgical Wound Dehiscence
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