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Soft Tissue Thickness on Submerged and Non Submerged Implants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02842385
Enrollment
35
Registered
2016-07-22
Start date
2009-10-31
Completion date
2011-11-30
Last updated
2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulousness, Tooth Loss

Keywords

soft tissue thickness, dental implant, crestal bone loss

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.

Interventions

OTHERImplant

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

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Crestal bone lossChange from baseline crestal bone level at 4th month after placement,Crestal bone loss was measured on radiographs between baseline-4th month after placement

Secondary

MeasureTime frameDescription
Probing depthEvaluation of probing depth at 4th month after placement (mm)Probing depth was measured with a plastic periodontal probe at 4th month after placement
Keratinized tissue levelEvaluation of keratinized tissue level at 4th month after placement (mm)Keratinized tissue level measured with a plastic periodontal probe at 4th month after placement
Modified plaque indexModified plaque index was recorded at 4th month after implant placementModified plaque index was recorded at medial and distal surface of implants
Modified sulcus bleeding indexModified sulcus bleeding index was recorded at 4th month after implant placementModified sulcus bleeding index was recorded after 10 second of probing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026