Clinical trial NCT02842385: Soft Tissue Thickness on Submerged and Non Submerged Implants
Official title: The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Edentulousness
Keywords: soft tissue thickness
dental implant
crestal bone loss
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Crestal bone loss
timeFrame: Change from baseline crestal bone level at 4th month after placement,
measure: Crestal bone loss
timeFrame: Change from baseline crestal bone level at 6th month after placement,
measure: Crestal bone loss
timeFrame: Change from baseline crestal bone level at 12th month after placement,
measure: Crestal bone loss
timeFrame: Change from baseline crestal bone level at 18th month after placement,
Secondary outcomes:
measure: Probing depth
timeFrame: Evaluation of probing depth at 4th month after placement (mm)
measure: Probing depth
timeFrame: Evaluation of probing depth at 6th month after placement (mm)
measure: Probing depth
timeFrame: Evaluation of probing depth at 12th month after placement (mm)
measure: Probing depth
timeFrame: Evaluation of probing depth at 18th month after placement (mm)
measure: Keratinized tissue level
timeFrame: Evaluation of keratinized tissue level at 4th month after placement (mm)
measure: Keratinized tissue level
timeFrame: Evaluation of keratinized tissue level at 6th month after placement (mm)
measure: Keratinized tissue level
timeFrame: Evaluation of keratinized tissue level at 12th month after placement (mm)
measure: Keratinized tissue level
timeFrame: Evaluation of keratinized tissue level at 18th month after placement (mm)
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at 4th month after implant placement
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at 6th month after implant placement
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at 12th month after implant placement
measure: Modified plaque index
timeFrame: Modified plaque index was recorded at 18th month after implant placement
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at 4th month after implant placement
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at 6th month after implant placement
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at 12th month after implant placement
measure: Modified sulcus bleeding index
timeFrame: Modified sulcus bleeding index was recorded at 18th month after implant placement
Other outcomes:
Locations:
Study officials:
affiliation: Ege University, School of Dentistry
name: Deniz Cengiz Özkaya, PhD,DDS
role: PRINCIPAL_INVESTIGATOR
References: