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Soft Tissue Thickness on Submerged and Non Submerged Implants

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ClinicalTrials.gov Identifier: NCT02842385
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Deniz Cengiz Özkaya, Ege University

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.

Condition or disease Intervention/treatment Phase
Tooth Loss Edentulousness Other: Implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study
Study Start Date : October 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Active Comparator: Nonsubmerged thick group
Nonsubmerged type of implants placed with thick (>3 mm) soft tissue
Other: Implant
One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Active Comparator: Nonsubmerged thin group
Nonsubmerged type of implants placed with thin (<3 mm) soft tissue
Other: Implant
One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Active Comparator: Submerged thick group
Submerged type of implants placed with thick (>3 mm) soft tissue
Other: Implant
One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Active Comparator: Submerged thin group
Submerged type of implants placed with thin (<3 mm) soft tissue
Other: Implant
One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842385


Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Deniz Cengiz Özkaya, PhD,DDS Ege University, School of Dentistry
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Responsible Party: Deniz Cengiz Özkaya, PhD, DDS, Ege University
ClinicalTrials.gov Identifier: NCT02842385    
Other Study ID Numbers: DCO-16
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Deniz Cengiz Özkaya, Ege University:
soft tissue thickness
dental implant
crestal bone loss
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases