Clinical trial NCT05014763: Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Ridge Augmentation
Tissue Transplantation
Tissue Donors
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: soft tissue volume change 0-3
timeFrame: from baseline (immediately before surgery) to 3 months
measure: soft tissue volume change 0-6
timeFrame: from baseline (immediately before surgery) to 6 months
measure: soft tissue volume change 3-6
timeFrame: from 3 months to 6 months
Secondary outcomes:
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: immediately after surgery
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 1
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 2
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 3
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 4
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 5
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 6
measure: The level of the pain by questionnaire through visual analogue scale
timeFrame: day 7
measure: Palliative 0-7
timeFrame: immediately after surgery to 7 days later
measure: Pink aesthetic score
timeFrame: 3 months after surgery
measure: Pink aesthetic score
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Neda Moslemi, Periodontist
role: PRINCIPAL_INVESTIGATOR
References: