Soft Tissue Thickness on Submerged and Non Submerged Implants

Study Overview
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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.

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

Conditions
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Tooth Loss, Edentulousness

Intervention / Treatment
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* Other: Implant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nonsubmerged thick group<br>Nonsubmerged type of implants placed with thick (>3 mm) soft tissue | Other: Implant<br>* One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement<br>|
| Active Comparator: Nonsubmerged thin group<br>Nonsubmerged type of implants placed with thin (<3 mm) soft tissue | Other: Implant<br>* One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement<br>|
| Active Comparator: Submerged thick group<br>Submerged type of implants placed with thick (>3 mm) soft tissue | Other: Implant<br>* One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement<br>|
| Active Comparator: Submerged thin group<br>Submerged type of implants placed with thin (<3 mm) soft tissue | Other: Implant<br>* One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, | 
| 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, | 
| 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, | 
| 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, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soft tissue thickness, dental implant, crestal bone loss