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

NCT ID: NCT02996370

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Tooth Loss Bone Loss

Keywords

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esthetic inter-implant papilla soft tissue tickness crestal bone loss second stage surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test group- ı shape incision

Second stage surgery was made I shape incision technique .

Group Type ACTIVE_COMPARATOR

papilla fill index

Intervention Type OTHER

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 loss

Intervention Type OTHER

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 depth

Intervention Type OTHER

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

Modified sulcus bleeding index

Intervention Type OTHER

Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Modified plaque index

Intervention Type OTHER

Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Control group- midcrestal incision

In the control group second stage surgery was made using the conventional method, midcrestal technique.

Group Type ACTIVE_COMPARATOR

papilla fill index

Intervention Type OTHER

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 loss

Intervention Type OTHER

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 depth

Intervention Type OTHER

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

Modified sulcus bleeding index

Intervention Type OTHER

Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Modified plaque index

Intervention Type OTHER

Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Interventions

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papilla fill index

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.

Intervention Type OTHER

crestal bone loss

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)

Intervention Type OTHER

probing depth

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

Intervention Type OTHER

Modified sulcus bleeding index

Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Intervention Type OTHER

Modified plaque index

Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Özge PEHLİVANOĞLU

Özge PEHLİVANOĞLU, PhD,DDS Ege University, School of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EGE-OP 2013

Identifier Type: -

Identifier Source: org_study_id