Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity

Not Applicable

• Conditions: Alveolar Ridge Augmentation; Tissue Donors; Tissue Transplantation
• Interventions: Procedure: connective tissue graft

• Registration Number: NCT05014763
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.

Detailed Description

Ridge resorption is a common finding after tooth extraction. Recently, there is an increasing concern about this issue during implant-supported reconstruction in the esthetic zone. Although the previous studies supports the guided bone regeneration procedures for reconstruction of contour deficiencies, the replacement of the mineralized materials with the bone has been questioned. Therefore, recently, using connective tissue grafts instead of allogenic or xenogenic materials has been addressed.

The palate is routinely used as the donor site for harvesting the connective tissue graft. The graft can be harvested by de-epithelialized method or it can be harvested conventionally from deep palate during flap elevation. Another choice for harvesting the connective tissue graft is the tuberosity area, which can be used when you need small to moderate amount of soft tissue (around 1-2 implants). The connective tissues harvested from these sites have quite different characteristics, which might influence on the fate of the treatment in terms of the stability.

therefore, we decided to compare the stability of the grafts harvested from the deep palate or tuberosity.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20
• Study Start: 2021-09-20
• Primary Completion: 2022-09-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. more than 18 years old.
2. systemically and periodontally healthy patients.
3. need of single implant placement between two maxillary teeth.
4. need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres .
5. more than 3 month after extraction.
6. full mouth plaque index lesser than 20%.
7. sufficient mesiodistal and buccolingual space.
8. At least 10 millimetres mesiodistal dimension in tuberosity.
9. sufficient implant primary stability.
10. at least 6 mm crestal ridge width.

Exclusion Criteria

1. History of periodontitis and radiotherapy.
2. Need of horizontal ridge augmentation.
3. Previous soft tissue augmentation.
4. Heavy smoker( more than 10 cigarette per day)
5. Local or systemic conditions that would interfere with routine periodontal therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTG from deep palate	connective tissue graft	The connective tissue graft harvested from the deep palate during flap elevation for implant placement
CTG from tuberosity	connective tissue graft	The connective tissue graft harvested from the tuberosity

Primary Outcome Measures

Name	Time	Method
soft tissue volume change 0-3	from baseline (immediately before surgery) to 3 months	changes of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner
soft tissue volume change 0-6	from baseline (immediately before surgery) to 6 months	changes of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner
soft tissue volume change 3-6	from 3 months to 6 months	changes of soft tissue volume from 3 months to 6 months by intra oral scanner

Secondary Outcome Measures

Name	Time	Method
The level of the pain by questionnaire through visual analogue scale	day 7	evaluation of the level of the pain by questionnaire through visual analogue scale method
Palliative 0-7	immediately after surgery to 7 days later	the number of palliatives the patient used during the first week after surgery
Pink aesthetic score	6 months after surgery	evaluation of the aesthetic score by photography

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of