Clinical trial NCT03834649: Pontic Site Development Using Soft Tissue Augmentation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alveolar Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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):

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.

Eligibility 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.

Primary outcomes:
measure: Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
timeFrame: 6 month
Secondary outcomes:
measure: 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)
timeFrame: 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: