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

Alveolar Ridge Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05014763
• Other study ID #: 9811213001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: July 2021
• Source: Tehran University of Medical Sciences
• Contact: Neda Moslemi, Periodontist
• Phone: +989128985838
• Email: neda_moslemi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: December 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation
• Tissue Donors
• Tissue Transplantation

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Palliative 0-7	the number of palliatives the patient used during the first week after surgery	immediately after surgery to 7 days later
Secondary	Pink aesthetic score	evaluation of the aesthetic score by photography	3 months after surgery
Secondary	Pink aesthetic score	evaluation of the aesthetic score by photography	6 months after surgery