ClinicalTrials.gg
CompletedNCT02842385Updated Jul 22, 2016

Soft Tissue Thickness on Submerged and Non Submerged Implants

An interventional study of Implant in Tooth Loss and Edentulousness, sponsored by Ege University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Loss
  • Edentulousness

Browse trials for

Keywords

  • soft tissue thickness
  • dental implant
  • crestal bone loss
03

In context

Tooth Loss

227 studies on the registry are indexed under Tooth Loss; 49 are open to participants now.

This study's enrollment of 35 is above the median of 30 across 169 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • poor oral hygiene
  • history of periodontitis
  • smoking
  • diabetes
  • alcoholism
  • taking medication which interferes soft and hard tissue healing
  • bruxism.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    Nonsubmerged thick group

    Nonsubmerged type of implants placed with thick (\>3 mm) soft tissue

    Other: Implant

  • Active comparator
    Nonsubmerged thin group

    Nonsubmerged type of implants placed with thin (\<3 mm) soft tissue

    Other: Implant

  • Active comparator
    Submerged thick group

    Submerged type of implants placed with thick (\>3 mm) soft tissue

    Other: Implant

  • Active comparator
    Submerged thin group

    Submerged type of implants placed with thin (\<3 mm) soft tissue

    Other: Implant

Interventions

  • OtherImplant

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

06

What researchers measure

Primary outcomes

  1. Crestal bone loss

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

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

  2. Crestal bone loss

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

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

  3. Crestal bone loss

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

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

  4. Crestal bone loss

    Crestal bone loss was measured on radiographs between baseline-18th month after placement

    Time frame: Change from baseline crestal bone level at 18th month after placement,

Secondary outcomes

  1. Probing depth

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

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

  2. Probing depth

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

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

  3. Probing depth

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

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

  4. Probing depth

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

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

  5. Keratinized tissue level

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

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

  6. Keratinized tissue level

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

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

  7. Keratinized tissue level

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

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

  8. Keratinized tissue level

    Keratinized tissue level measured with a plastic periodontal probe at 18th month after placement

    Time frame: Evaluation of keratinized tissue level at 18th month after placement (mm)

  9. Modified plaque index

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

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

  10. Modified plaque index

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

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

  11. Modified plaque index

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

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

  12. Modified plaque index

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

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

  13. Modified sulcus bleeding index

    Modified sulcus bleeding index was recorded after 10 second of probing

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

  14. Modified sulcus bleeding index

    Modified sulcus bleeding index was recorded after 10 second of probing

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

  15. Modified sulcus bleeding index

    Modified sulcus bleeding index was recorded after 10 second of probing

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

  16. Modified sulcus bleeding index

    Modified sulcus bleeding index was recorded after 10 second of probing

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Nov 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2016
First posted
Jul 22, 2016
Start
Oct 2009
Primary completionActual
Nov 2011
CompletionActual
Nov 2011
Last update
Jul 22, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02842385
Lead sponsor
Ege University
Responsible party
Deniz Cengiz Özkaya (PhD, DDS, Ege University) — Principal investigator
First posted
Jul 22, 2016
Start date
Oct 2009
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jul 22, 2016

Study contacts

Deniz Cengiz Özkaya, PhD,DDS
principal investigator · Ege University, School of Dentistry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion