Dental ImplantNCT07769125
Peri-implant Soft Tissue Phenotype and Early Marginal Bone Loss After Dental Implant Placement
An observational study of Dental Implant, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study evaluated the relationship between peri-implant soft tissue characteristics and early marginal bone loss following dental implant placement. The study included patients receiving bone-level implants in posterior edentulous regions. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Dental Implant
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2023to 15 Jan 2026
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients presenting to the Department of Periodontology, Faculty of Dentistry, Ankara University, for implant-supported rehabilitation of posterior edentulous regions were considered for participation in this prospective cohort study. Eligible patients who underwent bone-level dental implant placement and agreed to participate were prospectively enrolled.
Who may be able to join
- Age between 20 and 60 years. Good general health. Need for dental implant treatment in a posterior edentulous region. Adequate native bone volume for implant placement without bone augmentation. At least 3 months since tooth extraction at the planned implant site. Presence of stable opposing teeth. Adequate oral hygiene. Ability to attend follow-up visits
Who cannot join
- Heavy smoking. Uncontrolled systemic disease. Pregnancy. Use of antibiotics or anti-inflammatory medications within the previous 3 months.
- Bruxism. Poor oral hygiene. Need for bone augmentation at the implant site.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Ankara, 06560
About this study
Official title: Impact of Peri-implant Soft Tissue Phenotype on Early Marginal Bone Loss: A Prospective Cohort Study
This prospective observational cohort study evaluated the relationship between peri-implant soft tissue characteristics and early marginal bone loss following dental implant placement. The study included patients receiving bone-level implants in posterior edentulous regions. Keratinized mucosa width, supracrestal tissue height, and mucosal thickness were measured at the time of implant placement. Marginal bone levels were assessed using standardized intraoral radiographs obtained at baseline and three months after implant placement. The primary aim was to determine whether these peri-implant soft tissue dimensions were associated with marginal bone loss during the early healing period.
Read the detailed description
This prospective observational cohort study was conducted at the Department of Periodontology, Faculty of Dentistry, Ankara University. Participants requiring implant-supported rehabilitation in posterior edentulous regions were prospectively enrolled and received bone-level dental implants according to a standardized surgical protocol. No participant was assigned to a treatment or exposure group for research purposes.
Peri-implant soft tissue dimensions were clinically assessed at the time of implant placement. Keratinized mucosa width was measured as the distance from the mucogingival junction to the mid-crestal point of the edentulous ridge. Supracrestal tissue height was determined following flap elevation as the vertical distance from the alveolar crest to the free gingival margin. Mucosal thickness was measured horizontally at the mid-buccal aspect using an endodontic file with a silicone stop.
Standardized intraoral periapical radiographs were obtained at implant placement and at the three-month follow-up using a parallel technique with individualized positioning. Radiographic measurements were calibrated according to the known implant length. Marginal bone level was determined on the mesial and distal aspects of each implant relative to the implant platform, and changes between baseline and the three-month follow-up were used to assess early marginal bone remodeling. Radiographic measurements were performed by a calibrated examiner blinded to the clinical soft tissue measurements.
The study was designed to examine the associations between peri-implant soft tissue dimensions and early marginal bone changes during healing after implant placement. Statistical analyses evaluated these relationships using both univariable and multivariable approaches while accounting for the distribution and structure of the collected data.
- Conditions
- Dental Implant
- Keywords
- dental implants, peri-implant soft tissue, peri-implant phenotype, marginal bone loss, keratinized mucosa, supracrestal tissue height, mucosal thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Dental Implants | A single prospective cohort of patients receiving bone-level dental implants in posterior edentulous regions. Peri-implant soft tissue dimensions, including keratinized mucosa width, supracrestal tissue height, and mucosal thickness, were measured at implant placement. Participants were not assigned to groups based on these measurements; soft tissue dimensions were evaluated as observational exposure variables in relation to marginal bone changes during the three-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss Around Dental Implants
Marginal bone loss was determined from standardized intraoral periapical radiographs obtained at implant placement (baseline) and at the three-month follow-up. Marginal bone level was measured on the mesial and distal aspects of each implant as the distance from the implant platform to the first bone-to-implant contact. Measurements were calibrated using the known implant length. Marginal bone loss was calculated as the change in marginal bone level from baseline to three months, and the mean of the mesial and distal measurements was used for analysis. Higher values indicate greater marginal bone loss.
Measured: Baseline to 3 months 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 posted17 Aug 2026
- Study start8 Aug 2023
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevilay Yeğinoğlu, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769125
- Sponsor's protocol ID
- 10/13
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations. Aggregated study findings will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peri-implant Soft Tissue Phenotype on Early Marginal Bone Loss: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07769125
- Acronym / sponsor ID
- 10/13
- Conditions
- Dental Implant
- Keywords
- dental implants, peri-implant soft tissue, peri-implant phenotype, marginal bone loss, keratinized mucosa, supracrestal tissue height, mucosal thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 17 Aug 2026 (actual)
- 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.
This prospective observational cohort study evaluated the relationship between peri-implant soft tissue characteristics and early marginal bone loss following dental implant placement. The study included patients receiving bone-level implants in posterior edentulous regions. Keratinized mucosa width, supracrestal tissue height, and mucosal thickness were measured at the time of implant placement. Marginal bone levels were assessed using standardized intraoral radiographs obtained at baseline and three months after implant placement. The primary aim was to determine whether these peri-implant soft tissue dimensions were associated with marginal bone loss during the early healing period.
Detailed description
This prospective observational cohort study was conducted at the Department of Periodontology, Faculty of Dentistry, Ankara University. Participants requiring implant-supported rehabilitation in posterior edentulous regions were prospectively enrolled and received bone-level dental implants according to a standardized surgical protocol. No participant was assigned to a treatment or exposure group for research purposes.
Peri-implant soft tissue dimensions were clinically assessed at the time of implant placement. Keratinized mucosa width was measured as the distance from the mucogingival junction to the mid-crestal point of the edentulous ridge. Supracrestal tissue height was determined following flap elevation as the vertical distance from the alveolar crest to the free gingival margin. Mucosal thickness was measured horizontally at the mid-buccal aspect using an endodontic file with a silicone stop.
Standardized intraoral periapical radiographs were obtained at implant placement and at the three-month follow-up using a parallel technique with individualized positioning. Radiographic measurements were calibrated according to the known implant length. Marginal bone level was determined on the mesial and distal aspects of each implant relative to the implant platform, and changes between baseline and the three-month follow-up were used to assess early marginal bone remodeling. Radiographic measurements were performed by a calibrated examiner blinded to the clinical soft tissue measurements.
The study was designed to examine the associations between peri-implant soft tissue dimensions and early marginal bone changes during healing after implant placement. Statistical analyses evaluated these relationships using both univariable and multivariable approaches while accounting for the distribution and structure of the collected data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Dental Implants | – | –A single prospective cohort of patients receiving bone-level dental implants in posterior edentulous regions. Peri-implant soft tissue dimensions, including keratinized mucosa width, supracrestal tissue height, and mucosal thickness, were measured at implant placement. Participants were not assigned to groups based on these measurements; soft tissue dimensions were evaluated as observational exposure variables in relation to marginal bone changes during the three-month follow-up. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients presenting to the Department of Periodontology, Faculty of Dentistry, Ankara University, for implant-supported rehabilitation of posterior edentulous regions were considered for participation in this prospective cohort study. Eligible patients who underwent bone-level dental implant placement and agreed to participate were prospectively enrolled.
Key inclusion criteria (1 listed)
- Age between 20 and 60 years. Good general health. Need for dental implant treatment in a posterior edentulous region. Adequate native bone volume for implant placement without bone augmentation. At least 3 months since tooth extraction at the planned implant site. Presence of stable opposing teeth. Adequate oral hygiene. Ability to attend follow-up visits
Key exclusion criteria (2 listed)
- Heavy smoking. Uncontrolled systemic disease. Pregnancy. Use of antibiotics or anti-inflammatory medications within the previous 3 months.
- Bruxism. Poor oral hygiene. Need for bone augmentation at the implant site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Marginal Bone Loss Around Dental Implants
Time frame: Baseline to 3 months after implant placement
Marginal bone loss was determined from standardized intraoral periapical radiographs obtained at implant placement (baseline) and at the three-month follow-up. Marginal bone level was measured on the mesial and distal aspects of each implant as the distance from the implant platform to the first bone-to-implant contact. Measurements were calibrated using the known implant length. Marginal bone loss was calculated as the change in marginal bone level from baseline to three months, and the mean of the mesial and distal measurements was used for analysis. Higher values indicate greater marginal bone loss.
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 17 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations. Aggregated study findings will be reported in scientific publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant, run by Karabuk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Marginal Bone Loss Around Dental Implants (time frame: Baseline to 3 months after implant placement). 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 17 Aug 2026.