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

NCT ID: NCT05014763

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Alveolar Ridge Augmentation Tissue Transplantation Tissue Donors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CTG from deep palate

The connective tissue graft harvested from the deep palate during flap elevation for implant placement

Group Type ACTIVE_COMPARATOR

connective tissue graft

Intervention Type PROCEDURE

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.

CTG from tuberosity

The connective tissue graft harvested from the tuberosity

Group Type EXPERIMENTAL

connective tissue graft

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neda Moslemi, Periodontist

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Central Contacts

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Neda Moslemi, Periodontist

Role: CONTACT

+989128985838

Facility Contacts

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Neda Moslemi, Periodontist

Role: primary

+982188492345

Mohadeseh Heidari, Periodontist

Role: backup

982188492345

Other Identifiers

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9811213001

Identifier Type: -

Identifier Source: org_study_id

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