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Completed

NCT Number: NCT02842385

Soft Tissue Thickness on Submerged and Non Submerged Implants

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.

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Key information

Conditions

Tooth Loss Edentulousness Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant

Other

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

Primary outcomes

  1. Crestal bone loss

    Time frame: Change from baseline crestal bone level at 4th month after placement,

    Crestal bone loss was measured on radiographs between baseline-4th month after placement

  2. Crestal bone loss

    Time frame: Change from baseline crestal bone level at 6th month after placement,

    Crestal bone loss was measured on radiographs between baseline-6th month after placement

  3. Crestal bone loss

    Time frame: Change from baseline crestal bone level at 12th month after placement,

    Crestal bone loss was measured on radiographs between baseline-12th month after placement

  4. Crestal bone loss

    Time frame: 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 outcomes

  1. Probing depth

    Time frame: Evaluation of probing depth at 4th month after placement (mm)

    Probing depth was measured with a plastic periodontal probe at 4th month after placement

  2. Probing depth

    Time frame: Evaluation of probing depth at 6th month after placement (mm)

    Probing depth was measured with a plastic periodontal probe at 6th month after placement

  3. Probing depth

    Time frame: Evaluation of probing depth at 12th month after placement (mm)

    Probing depth was measured with a plastic periodontal probe at 12th month after placement

  4. Probing depth

    Time frame: Evaluation of probing depth at 18th month after placement (mm)

    Probing depth was measured with a plastic periodontal probe at 18th month after placement

  5. Keratinized tissue level

    Time frame: Evaluation of keratinized tissue level at 4th month after placement (mm)

    Keratinized tissue level measured with a plastic periodontal probe at 4th month after placement

  6. Keratinized tissue level

    Time frame: Evaluation of keratinized tissue level at 6th month after placement (mm)

    Keratinized tissue level measured with a plastic periodontal probe at 6th month after placement

  7. Keratinized tissue level

    Time frame: Evaluation of keratinized tissue level at 12th month after placement (mm)

    Keratinized tissue level measured with a plastic periodontal probe at 12th month after placement

  8. Keratinized tissue level

    Time frame: 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

  9. Modified plaque index

    Time frame: Modified plaque index was recorded at 4th month after implant placement

    Modified plaque index was recorded at medial and distal surface of implants

  10. Modified plaque index

    Time frame: Modified plaque index was recorded at 6th month after implant placement

    Modified plaque index was recorded at medial and distal surface of implants

  11. Modified plaque index

    Time frame: Modified plaque index was recorded at 12th month after implant placement

    Modified plaque index was recorded at medial and distal surface of implants

  12. Modified plaque index

    Time frame: Modified plaque index was recorded at 18th month after implant placement

    Modified plaque index was recorded at medial and distal surface of implants

  13. Modified sulcus bleeding index

    Time frame: Modified sulcus bleeding index was recorded at 4th month after implant placement

    Modified sulcus bleeding index was recorded after 10 second of probing

  14. Modified sulcus bleeding index

    Time frame: Modified sulcus bleeding index was recorded at 6th month after implant placement

    Modified sulcus bleeding index was recorded after 10 second of probing

  15. Modified sulcus bleeding index

    Time frame: Modified sulcus bleeding index was recorded at 12th month after implant placement

    Modified sulcus bleeding index was recorded after 10 second of probing

  16. Modified sulcus bleeding index

    Time frame: Modified sulcus bleeding index was recorded at 18th month after implant placement

    Modified sulcus bleeding index was recorded after 10 second of probing

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2016
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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