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

Not Applicable

Completed

• Conditions: Tooth Loss; Bone Loss
• Interventions: Other: papilla fill index; Other: crestal bone loss; Other: probing depth; Other: Modified sulcus bleeding index; Other: Modified plaque index

• Registration Number: NCT02996370
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2016-12
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-19
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group- midcrestal incision	crestal bone loss	In the control group second stage surgery was made using the conventional method, midcrestal technique.
Control group- midcrestal incision	Modified plaque index	In the control group second stage surgery was made using the conventional method, midcrestal technique.
Test group- ı shape incision	probing depth	Second stage surgery was made I shape incision technique .
Test group- ı shape incision	papilla fill index	Second stage surgery was made I shape incision technique .
Test group- ı shape incision	Modified plaque index	Second stage surgery was made I shape incision technique .
Control group- midcrestal incision	Modified sulcus bleeding index	In the control group second stage surgery was made using the conventional method, midcrestal technique.
Test group- ı shape incision	crestal bone loss	Second stage surgery was made I shape incision technique .
Test group- ı shape incision	Modified sulcus bleeding index	Second stage surgery was made I shape incision technique .
Control group- midcrestal incision	papilla fill index	In the control group second stage surgery was made using the conventional method, midcrestal technique.
Control group- midcrestal incision	probing depth	In the control group second stage surgery was made using the conventional method, midcrestal technique.

Primary Outcome Measures

Name	Time	Method
papilla fill index	6 month	Papilla fill index will be recorded 6th month after baseline
crestal bone loss	Change from baseline crestal bone level up to 6 months	Crestal bone loss was measured on radiographs between baseline-6th month.
vertical distance	baseline, 3 and 6 month	Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.

Secondary Outcome Measures

Name	Time	Method
Modified sulcus bleeding index	Modified sulcus bleeding index was recorded at 6 month	Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Modified plaque index	Modified plaque index was recorded at 6 month	The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Keratinized tissue level	Keratinized tissue level was recorded at 6 month	Keratinized tissue level measured with a plastic periodontal probe
Probing depth	6 month	The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.