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Evaluation of outcome of grafts harvested from different sites for treatment of edentulated areas

Comparison of stability of peri-implant buccal convexity following soft tissue augmentation harvested from the lateral palate or the tuberosity area: A randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210827052303N1
Enrollment
34
Registered
2021-11-15
Start date
2021-11-21
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Bone resorption and concavity of the buccal area of the edentulous space.

Interventions

Intervention 1: Intervention group:The tissue required for the transplant will be removed from the tuberosity area and covered with periodontal dressing. The epithelium will then be removed from the g

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: more than 18 years old. systemically and periodontally healthy patients. Need of single implant placement between two maxillary teeth. Need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres . More than 3 month after extraction. Full mouth plaque index lesser than 20%. Sufficient mesiodistal and buccolingual space. At least 10 millimetres mesiodistal dimension in tuberosity. Sufficient implant primary stability. At least 6 mm crestal ridge width.

Exclusion criteria

Exclusion criteria: History of periodontitis and radiotherapy. Need of horizontal ridge augmentation. Pregnants or heavy smokers ( more than 10 cigarette per day). Local or systemic conditions that would interfere with routine periodontal therapy. Previous soft tissue augmentation in the desired area.

Design outcomes

Primary

MeasureTime frame
Soft tissue volume: the amount of contracted connective tissue volume in the recipient area using superimposition of intraoral scanner images in millimeters. Timepoint: Soft tissue volume will examine by intraoral scanner before surgery and three and six months after surgery. Method of measurement: Intraoral scanner (Medit-i500, Korea) is used to examine the volume changes of soft tissue.

Secondary

MeasureTime frame
Keratinized tissue width. Timepoint: It will measure when the patient is selected for admission, three and six months after surgery. Method of measurement: Using a UNC15 probe in millimeters.;Gingival phenotype. Timepoint: Before patient surgery. Method of measurement: Using the UNC15 probe, it will divide into two categories, thin and thick.;Pink esthetic score. Timepoint: Will be measure within six months follow up. Method of measurement: Evaluation of the aesthetic results of the soft tissue around the implant-based crown by considering the mesial and distal papillae, surface and color, contour and texture of the soft tissue and alveolar defects of the process will be done by photographic observation.;The amount of pain. Timepoint: It will check in the first seven days after surgery. Method of measurement: Measure by Visual analog scale.;Number of analgesics consumed. Timepoint: Number of analgesics used from the day of surgery to the time of suturing. Method of measurement: questionnaire.;Thickness of gingiva. Timepoint: Before surgery, three and six months after surgery. Method of measurement: Gingival thickness at 1, 3 and 5 mm from the margin line connecting the surrounding teeth before surgery and at 1, 3 and 5 mm from the implant prosthesis margin, three and six months after surgery.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Shokri Vahed

Tehran University of Medical Sciences

mohammad.shokri_v@yahoo.com+98 21 8835 1170

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026