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

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

Study Overview

• Status: Unknown
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Mucograft; Procedure: partially de-epithelized connective tissue graft

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):

The same operator (N M) will perform all procedures under local anesthesia (4% articaine with 1/200 000 adrenaline Solution), using a local infiltration technique.

The recipient site will be prepared using 15c-blad creating a full-thickness coronal dissection and a partial thickness apical dissection creating a vestibular pouch.

The grafting procedure then performed and graft will be fixed by suturing at the periphery of the flap using 5/0 suture material and the rest will be inserted in the vestibular pouch.

The patient will have printed post-surgical instruction and precautions.

• Intervention for control group :

  1. The recipient site will be prepared with a full-thickness coronal dissection and a partial thickness apical dissection to creat a vestibular pouch.
  2. The acellular matrix (Mucograft®) will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch.

• Intervention for test group :

  1. The recipient site will be prepared with a full-thickness coronal dissection and a partial thickness apical dissection vestibular pouch.

  2. The graft which is composed of two parts:The coronal part, which is epithelialized

     • The apical part, which is formed of connective tissue only.
  3. On the defect area, the crestal surface is de-epithelialized with a beveled incision and the apical surface is prepared with a partial-thickness dissection with two vertical- releasing incisions extended apically, without involving the adjacent papillae, in order to create a pouch area.
  4. The onlay section (epithelialized area) of the graft will be sutured on the crestal surface of the defect, while the inlay section (connective tissue) will be inserted and secured in the vestibular pouch area.
• Post-operative care:

As with any regenerative site, caution must be exercised in post-operative care and during oral hygiene practices at or near the surgical site. After 12 hours 875 mg of Amoxicillin and 125 mg of Clavulanic acid tablet (1 g Amoxicillin Clavulanate) twice daily for 7 days, anti-inflammatory tablet (Amphiltirne ) if the patient need ,maximum three times/day and chlorhexidine HCL 1.25% mouth wash mouthwash twice daily are prescribed. Sutures will be removed after 14 days. (12)

* Follow-up (T1, T2,T3):

(T1):2 weeks post-operatively sutures removal . (T2) 3 months post-operatively appointments will be assigned for the prosthetic preparation and temporization for 2 weeks (T3): 6 months post-operatively appointments will be assigned for the prosthetic delivery and fill in the Questionnaire.

• Criteria for discontinuing intervention:

  • Infection and sloughing of the graft.
  • if the patient wouldn't commit to the follow-ups.
• Strategies to improve adherence to intervention protocol:

Patient preparation in terms of improving oral hygiene and first phase therapy procedures will be performed for patient to doctor trust. Complete information concerning the protocol will be provided and simplified to the patient with reasoning of all the steps included as the importance of the follow up visits and home medication.

Relevant concomitant care and interventions that are permitted or prohibited during the trial:

Postoperatively the patients will be using analgesics, oral antibiotic therapy, and chlorhexidine HCL 1.25% mouthwash mouthwash for at two week.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nouran A Mater, Master holder; Phone Number: 00201226953337; Email: nouranmater133@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Cairo University
    • Contact: Nouran A Mater, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	% 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

Collaborators and Investigators

• Sponsor: Nouran Abdulla Mater,MD

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): August 25, 2020
• Study Completion (Anticipated): September 25, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 271188

Drug and device information, study documents

• 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