Tooth LossNCT02842385
Soft Tissue Thickness on Submerged and Non Submerged Implants
A study testing Implant in people with Tooth Loss and Edentulousness, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Edentulousness
- What is being tested?
- Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- poor oral hygiene
- history of periodontitis
- smoking
- diabetes
- alcoholism
- taking medication which interferes soft and hard tissue healing
- bruxism.
About this study
Official title: The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study
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.
- Conditions
- Tooth Loss, Edentulousness
- Being tested
- Implant
- Keywords
- soft tissue thickness, dental implant, crestal bone loss
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantOther
One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement
| Study group | Role | What they receive |
|---|---|---|
| Nonsubmerged thick group | Active comparator | Nonsubmerged type of implants placed with thick (>3 mm) soft tissue Receives: Other: Implant |
| Nonsubmerged thin group | Active comparator | Nonsubmerged type of implants placed with thin (<3 mm) soft tissue Receives: Other: Implant |
| Submerged thick group | Active comparator | Submerged type of implants placed with thick (>3 mm) soft tissue Receives: Other: Implant |
| Submerged thin group | Active comparator | Submerged type of implants placed with thin (<3 mm) soft tissue Receives: Other: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss
Crestal bone loss was measured on radiographs between baseline-4th month after placement
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline crestal bone level at 18th month after placement,
Secondary outcomes (16)
Probing depth
Probing depth was measured with a plastic periodontal probe at 4th month after placement
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Modified sulcus bleeding index was recorded at 18th month after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Cengiz Özkaya, Ege University
- Investigators
- Deniz Cengiz Özkaya, PhD,DDS, Principal investigator, Ege University, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842385
- Sponsor's protocol ID
- DCO-16
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02842385
- Acronym / sponsor ID
- DCO-16
- Conditions
- Tooth Loss, Edentulousness
- Keywords
- soft tissue thickness, dental implant, crestal bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nonsubmerged thick group | Active comparator | Other: ImplantNonsubmerged type of implants placed with thick (>3 mm) soft tissue |
| Nonsubmerged thin group | Active comparator | Other: ImplantNonsubmerged type of implants placed with thin (<3 mm) soft tissue |
| Submerged thick group | Active comparator | Other: ImplantSubmerged type of implants placed with thick (>3 mm) soft tissue |
| Submerged thin group | Active comparator | Other: ImplantSubmerged type of implants placed with thin (<3 mm) soft tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- poor oral hygiene
- history of periodontitis
- smoking
- diabetes
- alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantOne or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement | Other | Nonsubmerged thick group, Nonsubmerged thin group, Submerged thick group, Submerged thin group |
Primary outcome
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
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
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
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
16 secondary outcomes
Probing depth
Time frame: Evaluation of probing depth at 4th month after placement (mm)
Probing depth
Time frame: Evaluation of probing depth at 6th month after placement (mm)
Probing depth
Time frame: Evaluation of probing depth at 12th month after placement (mm)
Probing depth
Time frame: Evaluation of probing depth at 18th month after placement (mm)
Keratinized tissue level
Time frame: Evaluation of keratinized tissue level at 4th month after placement (mm)
Keratinized tissue level
Time frame: Evaluation of keratinized tissue level at 6th month after placement (mm)
Keratinized tissue level
Time frame: Evaluation of keratinized tissue level at 12th month after placement (mm)
Keratinized tissue level
Time frame: Evaluation of keratinized tissue level at 18th month after placement (mm)
Modified plaque index
Time frame: Modified plaque index was recorded at 4th month after implant placement
Modified plaque index
Time frame: Modified plaque index was recorded at 6th month after implant placement
Modified plaque index
Time frame: Modified plaque index was recorded at 12th month after implant placement
Modified plaque index
Time frame: Modified plaque index was recorded at 18th month after implant placement
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at 4th month after implant placement
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at 6th month after implant placement
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at 12th month after implant placement
Modified sulcus bleeding index
Time frame: Modified sulcus bleeding index was recorded at 18th month after implant placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Cengiz Özkaya, PhD,DDS principal investigator
Ege University, School of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Implant in people with Tooth Loss and Edentulousness, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone loss (time frame: Change from baseline crestal bone level at 4th month after placement,). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016; AzTrials last refreshed its copy on 31 Oct 2026.