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Clinical Trials/NCT03696862
NCT03696862UnknownNot Applicable

Assessment of Collagen Plug Versus Free Gingival Graft for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone

Cairo University0 sites20 target enrollmentStarted: October 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Primary Endpoint
changes in soft tissue

Study Overview

Brief Summary

Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone.

It was observed that socket-healing process may be divided into three sequential, and frequently over-lapping phases: inflammatory, proliferative and modeling/remodeling.

Implants placed in fresh extraction sockets alone wasn't found to prevent the resorption of the alveolar bone.

Detailed Description

Alveolar socket preservation using primary flap closure technique utilizing free gingival graft in conjunction with bone substitutes didn't produce the desired effect on ridge preservation compared with bone substitutes alone. A clinical trial showed that achieving primary closure didn't present additional beneficial effect on preserving ridge width, however, the mucosa was significantly thicker and more coronally positioned.

Also soft tissue graft has its limitations on covering graft material and socket preservation due to the higher morbidity given that the soft tissue graft has to be harvested from a donor site of the patient.

Another options for socket seal are coronal advancement of buccal flap or rotating grafts from tissue adjacent to cover the defect but they have limitations such as altering the mucogingival line and creating a shallow vestibule.

Lekovic et al. investigated the use of a non-resorbable polytetrafluroethylene membrane but it was found also to have its limitations as 30% of the membranes became exposed and as a result loss of bone height and width occurred.

Also studies have found that using bone substitutes together with collagen membrane with primary closure of the socket has shown clear effects on preserving alveolar ridge height as well as ridge width, however, its limitation are flap dehiscence and subsequent membrane exposure and the increased cost.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with maxillary teeth in the esthetic zone (incisors/premolars) requiring extractions.
  • •Both sexes.
  • •No intraoral soft and hard tissue pathology.
  • •No systemic condition that contraindicate implant placement.

Exclusion Criteria

  • •Uncontrolled periapical infections
  • •Heavy smokers more than 20 cigarettes per day.
  • •Patients with systemic disease that may affect normal healing.
  • •Psychiatric problems
  • •Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
  • •Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Arms & Interventions

collagen plug

Experimental

collagen plug used to seal the socket after atraumatic extraction of the badly deacayed teeth with immediate implant placement and bone graft

Intervention: free gingival graft (Procedure)

Outcomes

Primary Outcomes

changes in soft tissue

Time Frame: 3 month

soft tissue changes will be measured in millimeters clinically and on a cast before and after the procedure

changes in bone

Time Frame: 6 month

bone loss and gain will be measured in millimeters using cone beam computed tomography before and after the procedure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

sara elsandouby

principal investigator

Cairo University

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