Wound DehiscenceNCT05513222
Flipped Autograft for Treating Surgical Wound Dehiscence
A study testing flipped autograft in people with Wound Dehiscence, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Dehiscence
- What is being tested?
- flipped autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2021to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flipped Autograft: a Novel Approach for Management of Wound Dehiscence in Implant Dentistry
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.
- Conditions
- Wound Dehiscence
- Being tested
- flipped autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flipped autograftProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| flipped autograft | Experimental | Not described Receives: Procedure: flipped autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start22 Jul 2021
- Primary completion29 Jan 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound DehiscenceStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- British University In Egypt
- Responsible party
- Principal investigator, ahmed hamdy mahmoud, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513222
- Sponsor's protocol ID
- hamdy
- Status last verified
- Mar 2024
- First submitted
- 20 Aug 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flipped Autograft: a Novel Approach for Management of Wound Dehiscence in Implant Dentistry
- ClinicalTrials.gov ID
- NCT05513222
- Acronym / sponsor ID
- hamdy
- Conditions
- Wound Dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- British University In Egypt
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flipped autograft | Experimental | Procedure: flipped autograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flipped autograftThick lingual flap was de-epithelized and partially dissected to increase its length then flipped and sutured to the buccal flap to obtain primary closure | Procedure or surgery | flipped autograft |
Primary outcome
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
1 secondary outcome
esthetic outcome and patient satisfaction.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Wound Dehiscence
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flipped autograft in people with Wound Dehiscence, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete primary intention healing of the wound dehiscence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.