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Pontic Site Development Using Soft Tissue Augmentation

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ClinicalTrials.gov Identifier: NCT03834649
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nouran Abdulla Mater,MD, Cairo University

Brief Summary:
in patients with vertical or horizontal defective of there ridge it is difficult to have prosthetic restoration with natural appearance emetating and simulating the adjacent abutment emergence profile so this study aims to develop the defective area using two different materials of soft tissue grafting techniques to restore the missing tissue and regain soft tissue volume and profile

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Procedure: partially de-epithelized connective tissue graft Procedure: Mucograft Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Soft Tissue Biotype and Volume Stability After Soft Tissue Augmentation by Using Mucograft® Versus Partially De-epithelized Connective Tissue Graft to Enhance the Pontic Site in Single Missing Tooth With Deficient Ridge: Randomized Clinical Trial
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 25, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mucograft
Soft tissue augmentation of the defective alveolar ridge using Mucograft inside the prepared vestibular pouch leaving part of the mucograft exposed at the crestal area and will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch.
Procedure: Mucograft

For preprosthetic defects, a standard mucosal augmentation procedure, which is well reported in the literature, was performed. The surgical site produced by the surgery leaves a "denuded area" supraperiosteally that is addressed by "grafting" with a xenogeneic collagen membrane (Mucograft).

purpose of the surgery is to improve the quantity of attached mucosa to facilitate the final dental reconstruction

Other Names:
  • pontic site development
  • pre-prosthetic development

Experimental: Partially de-epithelialized connective tissue graft
Soft tissue augmentation of the defective alveolar ridge using Partially de-epithelialized connective tissue graft by preparing vestibular pouch at the defect site and place the de-epithelialized part inside the pouch leaving the epithelialized part sutured and exposed at the crestal area
Procedure: partially de-epithelized connective tissue graft
graft procedures to obtain simultaneous tissue augmentation in the horizontal and vertical dimensions. The donor site was prepared with a full-thickness coronal dissection and a partial-thickness apical dissection.The objectives were to use a single procedure to achieve simultaneously apico-coronal and buccolingual augmentation,to have a smaller open wound in the donor site and less patient discomfort, and to guarantee better revascularization of the onlay section aided by the submerged connective tissue section of the graft.
Other Names:
  • pontic site development
  • Combination onlay-inlay grafts




Primary Outcome Measures :
  1. Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa) [ Time Frame: 6 month ]
    % of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.


Secondary Outcome Measures :
  1. soft tissue stability (% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob) [ Time Frame: 6 month ]
    % of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob.



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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Single missing tooth and the patient decides to have fixed prosthesis as a treatment option for tooth replacement.
  • Horizontal and\or vertical ridge defect at the pontic site
  • Sufficient inter-arch distance.
  • Restorable neighbouring abutments.
  • Periodontally sound abutments.
  • Skilled and motivated patient in maintaining good oral hygiene.

Exclusion Criteria:

  • Multiple neighboring missing teeth.
  • Systemic diseases that could affect treatment outcome.
  • Poor oral hygiene.
  • Patient is not motivated to have the treatment.

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): NCT03834649


Contacts
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Contact: Nouran A Mater, Master holder 00201226953337 nouranmater133@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 002
Contact: Nouran A Mater, Master         
Sponsors and Collaborators
Nouran Abdulla Mater,MD

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Responsible Party: Nouran Abdulla Mater,MD, Lectural assistant, Cairo University
ClinicalTrials.gov Identifier: NCT03834649     History of Changes
Other Study ID Numbers: 271188
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases