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

Comparison of Peri-implant Tissue Stability Following Soft Tissue Augmentation Harvested From the Deep Palate or the Tuberosity Area: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tissue Transplantation; Alveolar Ridge Augmentation; Tissue Donors
• Intervention / Treatment: Procedure: connective tissue graft

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neda Moslemi, Periodontist; Phone Number: +989128985838; Email: neda_moslemi@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences
    • Contact: Neda Moslemi, Periodontist; Phone Number: +982188492345; Email: neda_moslemi@yahoo.com
    • Contact: Mohadeseh Heidari, Periodontist; Phone Number: 982188492345; Email: heidari_mohadeseh@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CTG from deep palate; The connective tissue graft harvested from the deep palate during flap elevation for implant placement	Procedure: connective tissue graft; Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.
Experimental: CTG from tuberosity; The connective tissue graft harvested from the tuberosity	Procedure: connective tissue graft; Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	immediately after surgery
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 1
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 2
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 3
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 4
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 5
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 6
The level of the pain by questionnaire through visual analogue scale	evaluation of the level of the pain by questionnaire through visual analogue scale method	day 7
Palliative 0-7	the number of palliatives the patient used during the first week after surgery	immediately after surgery to 7 days later
Pink aesthetic score	evaluation of the aesthetic score by photography	3 months after surgery
Pink aesthetic score	evaluation of the aesthetic score by photography	6 months after surgery

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Neda Moslemi, Periodontist, Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2021
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 9811213001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No