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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05014763
Enrollment
34
Registered
2021-08-20
Start date
2021-09-20
Completion date
2022-12-20
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Ridge Augmentation, Tissue Donors, Tissue Transplantation

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.

Interventions

PROCEDUREconnective 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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
soft tissue volume change 0-3from baseline (immediately before surgery) to 3 monthschanges of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner
soft tissue volume change 0-6from baseline (immediately before surgery) to 6 monthschanges of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner
soft tissue volume change 3-6from 3 months to 6 monthschanges of soft tissue volume from 3 months to 6 months by intra oral scanner

Secondary

MeasureTime frameDescription
The level of the pain by questionnaire through visual analogue scaleimmediately after surgeryevaluation of the level of the pain by questionnaire through visual analogue scale method
Palliative 0-7immediately after surgery to 7 days laterthe number of palliatives the patient used during the first week after surgery
Pink aesthetic score3 months after surgeryevaluation of the aesthetic score by photography

Countries

Iran

Contacts

Primary ContactNeda Moslemi, Periodontist
neda_moslemi@yahoo.com+989128985838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026