NCT05513222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

August 20, 2022

Last Update Submit

March 31, 2024

Conditions

Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • esthetic outcome and patient satisfaction.

    3 months

Study Arms (1)

flipped autograft

EXPERIMENTAL
Procedure: flipped autograft

Interventions

flipped autograftPROCEDURE

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

flipped autograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with any smoking habits. 2- Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.
  • Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
  • Patients with infections either periodontally or periapically.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Hamdy

Cairo, 11837, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 24, 2022

Study Start

July 22, 2021

Primary Completion

January 29, 2022

Study Completion

April 27, 2022

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations

EG(1)