Soft Tissue Thickness on Submerged and Non Submerged Implants

NCT ID: NCT02842385

Last Updated: 2016-07-22

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-11-30

Brief Summary

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Changes in the marginal bone level surrounding the implant are the frequently used parameters in assessing the short- and long-term success. Multiple biological and biomechanical factors have been reported to adversely affect marginal bone level. Recently, initial vertical mucosal tissue thickness has also been reported to have an impact on bone stability.The hypothesis of present study is that soft tissue thickness on implant placement has no positive impact of crestal bone remodeling.

Detailed Description

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The aim of this study is to evaluate the clinical and radiographical results of submerged and nonsubmerged implants with thin (\<3 mm) and thick (\>3 mm) soft tissue over 1.5 year after implant placement. All submerged and nonsubmerged implants were randomly placed as split-mouth. Clinical periodontal parameters were recorded. Crestal bone levels were analyzed from the day of implants inserted to 1.5 year after prosthetic loading on digitally standardized radiographs. Non-parametric test were used for statistically analysis.

Conditions

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Tooth Loss Edentulousness

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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Nonsubmerged thick group

Nonsubmerged type of implants placed with thick (\>3 mm) soft tissue

Group Type ACTIVE_COMPARATOR

Implant

Intervention Type OTHER

One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Nonsubmerged thin group

Nonsubmerged type of implants placed with thin (\<3 mm) soft tissue

Group Type ACTIVE_COMPARATOR

Implant

Intervention Type OTHER

One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Submerged thick group

Submerged type of implants placed with thick (\>3 mm) soft tissue

Group Type ACTIVE_COMPARATOR

Implant

Intervention Type OTHER

One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Submerged thin group

Submerged type of implants placed with thin (\<3 mm) soft tissue

Group Type ACTIVE_COMPARATOR

Implant

Intervention Type OTHER

One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Interventions

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Implant

One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being older than 18 years of age
* generally healthy patients, no medical contraindication for implant surgery
* missing teeth in upper jaw posterior and more than one tooth in neighbourhood area
* no bone augmentation procedures before and during implant placement.

Exclusion Criteria

* poor oral hygiene
* history of periodontitis
* smoking
* diabetes
* alcoholism
* taking medication which interferes soft and hard tissue healing
* 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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Deniz Cengiz Özkaya

PhD, DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz Cengiz Özkaya, PhD,DDS

Role: PRINCIPAL_INVESTIGATOR

Ege University, School of Dentistry

Other Identifiers

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DCO-16

Identifier Type: -

Identifier Source: org_study_id

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