Soft Tissue Thickness on Submerged and Non Submerged Implants

Tooth Loss Clinical Trial

Official title:

The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842385
• Other study ID #: DCO-16
• Status: Completed
• Phase: N/A
• First received: July 11, 2016
• Last updated: July 20, 2016
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2016
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edentulousness
• Tooth Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal bone loss	Crestal bone loss was measured on radiographs between baseline-4th month after placement	Change from baseline crestal bone level at 4th month after placement,	Yes
Primary	Crestal bone loss	Crestal bone loss was measured on radiographs between baseline-6th month after placement	Change from baseline crestal bone level at 6th month after placement,	Yes
Primary	Crestal bone loss	Crestal bone loss was measured on radiographs between baseline-12th month after placement	Change from baseline crestal bone level at 12th month after placement,	Yes
Primary	Crestal bone loss	Crestal bone loss was measured on radiographs between baseline-18th month after placement	Change from baseline crestal bone level at 18th month after placement,	Yes
Secondary	Probing depth	Probing depth was measured with a plastic periodontal probe at 4th month after placement	Evaluation of probing depth at 4th month after placement (mm)	Yes
Secondary	Probing depth	Probing depth was measured with a plastic periodontal probe at 6th month after placement	Evaluation of probing depth at 6th month after placement (mm)	Yes
Secondary	Probing depth	Probing depth was measured with a plastic periodontal probe at 12th month after placement	Evaluation of probing depth at 12th month after placement (mm)	Yes
Secondary	Probing depth	Probing depth was measured with a plastic periodontal probe at 18th month after placement	Evaluation of probing depth at 18th month after placement (mm)	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe at 4th month after placement	Evaluation of keratinized tissue level at 4th month after placement (mm)	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe at 6th month after placement	Evaluation of keratinized tissue level at 6th month after placement (mm)	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe at 12th month after placement	Evaluation of keratinized tissue level at 12th month after placement (mm)	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe at 18th month after placement	Evaluation of keratinized tissue level at 18th month after placement (mm)	Yes
Secondary	Modified plaque index	Modified plaque index was recorded at medial and distal surface of implants	Modified plaque index was recorded at 4th month after implant placement	Yes
Secondary	Modified plaque index	Modified plaque index was recorded at medial and distal surface of implants	Modified plaque index was recorded at 6th month after implant placement	Yes
Secondary	Modified plaque index	Modified plaque index was recorded at medial and distal surface of implants	Modified plaque index was recorded at 12th month after implant placement	Yes
Secondary	Modified plaque index	Modified plaque index was recorded at medial and distal surface of implants	Modified plaque index was recorded at 18th month after implant placement	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded after 10 second of probing	Modified sulcus bleeding index was recorded at 4th month after implant placement	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded after 10 second of probing	Modified sulcus bleeding index was recorded at 6th month after implant placement	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded after 10 second of probing	Modified sulcus bleeding index was recorded at 12th month after implant placement	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded after 10 second of probing	Modified sulcus bleeding index was recorded at 18th month after implant placement	Yes