Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

Ege University12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tooth Loss Bone Loss

Interventions

papilla fill indexOTHER

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.

crestal bone lossOTHER

Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

probing depthOTHER

The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

papilla fill index

Baseline will be 1 week after cementation of the crowns.

Time frame: baseline

papilla fill index

Papilla fill index will be recorded 3rd month after baseline

Time frame: 3 month

papilla fill index

Papilla fill index will be recorded 6th month after baseline

Time frame: 6 month

crestal bone loss

Crestal bone loss was measured on radiographs between baseline-3rd month.

Time frame: Change from baseline crestal bone level up to 3 months

crestal bone loss

Crestal bone loss was measured on radiographs between baseline-6th month.

Time frame: Change from baseline crestal bone level up to 6 months

vertical distance

Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.

Time frame: baseline, 3 and 6 month

Secondary Outcomes

Probing depth

The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.

Time frame: baseline

Probing depth

The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.

Time frame: 3 month

Data from ClinicalTrials.gov

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