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

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ClinicalTrials.gov Identifier: NCT03696862
Recruitment Status : Unknown
Verified October 2018 by sara elsandouby, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
sara elsandouby, Cairo University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Badly Decayed Upper Anterior Teeth Procedure: free gingival graft Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Collagen Plug Versus Free Gingival Graft for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
Estimated Study Start Date : October 20, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: collagen plug
collagen plug used to seal the socket after atraumatic extraction of the badly deacayed teeth with immediate implant placement and bone graft
 Procedure: free gingival graft
Use of free gingival graft to seal the socket after flapless atraumatic tooth extraction is performed, implant placement and filling the socket with bone graft.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696862


Contacts
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Contact: Sara MR Elsandouby, bachelor's 01281106660 saraelsandouby@outlook.com
Contact: Mohamed A Abdelrasoul, PhD 01009612708 zokasur@gmail.com

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: sara elsandouby, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03696862    
Other Study ID Numbers: CairoUimplant master porgram
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No