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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
Study Overview
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
Detailed Description
PICO P: single pontic site with deficient ridge. I: Soft tissue augmentation with partially de-epithelized connective tissue graft.
C: Soft tissue augmentation with Mucograft. O: Soft tissue biotype, Soft tissue volume, pain score and patient satisfaction.
Preoperative measures:
- All subjects will pass through phase I therapy (Supragingival scalling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
- After 4 weeks, all subjects will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash twice daily).
- Eligible patients will be randomized before being enrolled in the study. (T-1 +4 weeks)
- Study casts for case study will be fabricated and clinical photographs will be taken.
- Assessment of edentulous defect site and neighboring teeth will be performed by scanning the study casts.
Surgical phase (T0):
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Mucograft (Procedure)
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
Intervention: partially de-epithelized connective tissue graft (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Nouran Abdulla Mater,MD
Lectural assistant
Cairo University