Pontic Site Development Using Soft Tissue Augmentation
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
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2019
1 active site
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
First Submitted
Initial submission to the registry
January 22, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2020
CompletedFebruary 11, 2019
February 1, 2019
1.6 years
January 22, 2019
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
% of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.
6 month
Secondary Outcomes (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)
6 month
Study Arms (2)
Mucograft
ACTIVE COMPARATORSoft 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.
Partially de-epithelialized connective tissue graft
EXPERIMENTALSoft 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Multiple neighboring missing teeth.
- Systemic diseases that could affect treatment outcome.
- Poor oral hygiene.
- Patient is not motivated to have the treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cairo University
Cairo, 002, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lectural assistant
Study Record Dates
First Submitted
January 22, 2019
First Posted
February 8, 2019
Study Start
February 1, 2019
Primary Completion
August 25, 2020
Study Completion
September 25, 2020
Last Updated
February 11, 2019
Record last verified: 2019-02