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

T

Tehran University of Medical Sciences

Status

Unknown

Conditions

Tissue Donors
Alveolar Ridge Augmentation
Tissue Transplantation

Treatments

Procedure: connective tissue graft

Study type

Interventional

Funder types

Other

Identifiers

NCT05014763
9811213001

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

CTG from deep palate
Active Comparator group
Description:
The connective tissue graft harvested from the deep palate during flap elevation for implant placement
Treatment:
Procedure: connective tissue graft
CTG from tuberosity
Experimental group
Description:
The connective tissue graft harvested from the tuberosity
Treatment:
Procedure: connective tissue graft

Trial contacts and locations

1

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Central trial contact

Neda Moslemi, Periodontist

Data sourced from clinicaltrials.gov

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