Clinical trial NCT02996370: Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
Official title: Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Bone Loss
Keywords: esthetic
inter-implant papilla
soft tissue tickness
crestal bone loss
second stage surgery
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.

Detailed description: A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.

Eligibility criteria: Inclusion Criteria:

* No sistemic condition, and age \> 18 years,
* healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,
* in a need of at least two collateral implants in the maxilla from second premolar to second premolar
* sufficient keratinized tissue
* no bone augmentation procedures before implant placement
* use of tobacco 10N ≥ cigarettes daily
* sufficient distance between opposite occluding dentition at the proposed implant sites

Exclusion Criteria:

* history of aggressive periodontitis,
* systemic diseases such as diabetes
* pregnant or lactating women
* radiation therapy in the head and neck area wihtin the previous 12 months,
* heavy smokers
* bruxism.

Primary outcomes:
measure: papilla fill index
timeFrame: baseline
measure: papilla fill index
timeFrame: 3 month
measure: papilla fill index
timeFrame: 6 month
measure: crestal bone loss
timeFrame: Change from baseline crestal bone level up to 3 months
measure: crestal bone loss
timeFrame: Change from baseline crestal bone level up to 6 months
measure: vertical distance
timeFrame: baseline, 3 and 6 month
Secondary outcomes:
measure: Probing depth
timeFrame: baseline
measure: Probing depth
timeFrame: 3 month
measure: Probing depth
timeFrame: 6 month
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at baseline
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at 3 month
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at 6 month
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at baseline
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at 3 month
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at 6 month
measure: Keratinized tissue level
timeFrame: Keratinized tissue level was recorded at baseline
measure: Keratinized tissue level
timeFrame: Keratinized tissue level was recorded at 3 month
measure: Keratinized tissue level
timeFrame: Keratinized tissue level was recorded at 6 month
Other outcomes:
Locations:
Study officials:
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