Soft Tissue Thickness on Submerged and Non Submerged Implants

Not Applicable

Completed

• Conditions: Tooth Loss; Edentulousness
• Interventions: Other: Implant

• Registration Number: NCT02842385
• Lead Sponsor: Ege University

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-22
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Submerged thin group	Implant	Submerged type of implants placed with thin (\<3 mm) soft tissue
Submerged thick group	Implant	Submerged type of implants placed with thick (\>3 mm) soft tissue
Nonsubmerged thick group	Implant	Nonsubmerged type of implants placed with thick (\>3 mm) soft tissue
Nonsubmerged thin group	Implant	Nonsubmerged type of implants placed with thin (\<3 mm) soft tissue

Primary Outcome Measures

Name	Time	Method
Crestal bone loss	Change from baseline crestal bone level at 18th month after placement,	Crestal bone loss was measured on radiographs between baseline-18th month after placement

Secondary Outcome Measures

Name	Time	Method
Modified sulcus bleeding index	Modified sulcus bleeding index was recorded at 18th month after implant placement	Modified sulcus bleeding index was recorded after 10 second of probing
Keratinized tissue level	Evaluation of keratinized tissue level at 18th month after placement (mm)	Keratinized tissue level measured with a plastic periodontal probe at 18th month after placement
Modified plaque index	Modified plaque index was recorded at 18th month after implant placement	Modified plaque index was recorded at medial and distal surface of implants
Probing depth	Evaluation of probing depth at 18th month after placement (mm)	Probing depth was measured with a plastic periodontal probe at 18th month after placement