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

Sponsor
Tehran University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05014763
Collaborator
(none)
34
1
2
15
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: connective tissue graft
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  1. The level of the pain by questionnaire through visual analogue scale [immediately after surgery]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  2. The level of the pain by questionnaire through visual analogue scale [day 1]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  3. The level of the pain by questionnaire through visual analogue scale [day 2]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  4. The level of the pain by questionnaire through visual analogue scale [day 3]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  5. The level of the pain by questionnaire through visual analogue scale [day 4]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  6. The level of the pain by questionnaire through visual analogue scale [day 5]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  7. The level of the pain by questionnaire through visual analogue scale [day 6]

    evaluation of the level of the pain by questionnaire through visual analogue scale method

  8. 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

  9. Palliative 0-7 [immediately after surgery to 7 days later]

    the number of palliatives the patient used during the first week after surgery

  10. Pink aesthetic score [3 months after surgery]

    evaluation of the aesthetic score by photography

  11. Pink aesthetic score [6 months after surgery]

    evaluation of the aesthetic score by photography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tehran University of Medical Sciences Tehran Iran, Islamic Republic of

Sponsors and Collaborators

  • Tehran University of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05014763
Other Study ID Numbers:
  • 9811213001
First Posted:
Aug 20, 2021
Last Update Posted:
Aug 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 20, 2021