Peri Implant MucositisPSTHNCT07564687
Peri-Implant Soft Tissue and Health
An observational study of Peri Implant Mucositis, run by Tuğba ŞAHİN at 1 site in Turkey (Türkiye).
Trial summary
Implant patients who applied to Bolu Abant İzzet Baysal University provided anamnesis. The study included 165 people with 272 implants. The study includes implants that satisfied the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri Implant Mucositis
- What is being tested?
- Implant
- How many people
- 272 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2024to 3 Mar 2026
- How long will I take part?
- 1 Day
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have received implants
Who may be able to join
- Patients aged 18-65 years who were systemically healthy, had a controlled medical conditions, and had fixed prostheses on the implants for at least 1 year following functional prosthetic loading of the dental implants.
Who cannot join
- Individuals with bruxism; those who smoke, were pregnant, or were breastfeeding; those who used anti-inflammatory drugs, immunosuppressants, or medications affecting the mucosa and bone; those who had undergone peri-implant disease treatment after implant placement; and those with residual cement residue and peri-implantitis related to prosthesis design or incorrectly placed implants.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, Turkey, 14300
About this study
Official title: Peri-Implant Soft Tissue and Peri-Implant Health
Implant patients who applied to Bolu Abant İzzet Baysal University provided anamnesis. The study included 165 people with 272 implants. The study includes implants that satisfied the inclusion criteria. Plaque index (PI) [13], gingival index (GI) [14], bleeding on probing (BOP) [15], periodontal pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), GP, GT, and KTW were all assessed in every implant patient. The presence of peri-implant mucositis or peri-implant health was assessed using the collected indices and radiographs. The patients were split into two groups: those with peri-implant mucositis (136 implants) and those with peri-implant health (136 implants). We investigated the relationships between each parameter and periodontal health.
- Conditions
- Peri Implant Mucositis
- Being tested
- Implant
- Keywords
- Dental Implants, Gingiva, Peri-implant tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantOther
The classification of peri-implant diseases is based on clinical and radiographic criteria, distinguishing between peri-implant mucositis and peri-implantitis according to the presence of inflammation and bone loss.
| Study group | Role | What they receive |
|---|---|---|
| Peri-implant mucositis | In the absence of bone loss, peri-implant mucositis refers to inflammation of the mucosa surrounding endosseous tissue Receives: Other: Implant | |
| Periodontal health | Peri-implant health is characterized by the absence of erythema, bleeding on probing, swelling, and suppuration, and is synonymous with implant success Receives: Other: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival phenotype
If the probe was visible when placed in the sulcus, gingiva was classified as thin (≤1 mm), and if the reflection of the probe was not visible, it was classified as thick (> 1 mm).
Measured: Baseline
Secondary outcomes (8)
Periodontal pocket depth
The periodontal pocket depth is the measurement of the distance between the gingival margin and the most coronal region of the junctional epithelium.
Measured: Baseline
Bleeding on probing
The bleeding on probing index was established as the occurrence of bleeding in the sulcus, thirty seconds after measuring the depth of the periodontal pockets in all dental implant.
Measured: Baseline
Plaque index
An index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin. 0 is minimum and 3 is maximum. The situation worsens as the score increases.
Measured: Baseline
Gingival index
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. 0 is minimum and 3 is maximum.
Measured: Baseline
Clinical attachment level
The peri-implant clinical attachment level is determined by measuring the distance from the implant margin to the base of the mucosal sulcus using a Williams periodontal probe.
Measured: Baseline
Gingival recession
Gingival recession is the measured distance between the enamel-cementum and the gingival margin. Assessment was performed using a Williams periodontal probe.
Measured: Baseline
Gingival thickness
GT was measured by inserting a number eight canal file from the buccal side of the implant until it reached the alveolar bone and then securing it with a stopper to determine the distance.
Measured: Baseline
Keratinized tissue width
The width of the keratinized gingiva was measured via a periodontal probe from the mucogingival margin to the gingival margin.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start11 Jun 2024
- Primary completion2 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri Implant MucositisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 272 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tuğba ŞAHİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba ŞAHİN, Abant Izzet Baysal University
- Investigators
- TUGBA SAHIN, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564687
- Sponsor's protocol ID
- BAIBU-DH-TS-07
- Acronym
- PSTH
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Soft Tissue and Peri-Implant Health
- ClinicalTrials.gov ID
- NCT07564687
- Acronym / sponsor ID
- PSTH / BAIBU-DH-TS-07
- Conditions
- Peri Implant Mucositis
- Keywords
- Dental Implants, Gingiva, Peri-implant tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Tuğba ŞAHİNUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 4 May 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.
Implant patients who applied to Bolu Abant İzzet Baysal University provided anamnesis. The study included 165 people with 272 implants. The study includes implants that satisfied the inclusion criteria. Plaque index (PI) [13], gingival index (GI) [14], bleeding on probing (BOP) [15], periodontal pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), GP, GT, and KTW were all assessed in every implant patient. The presence of peri-implant mucositis or peri-implant health was assessed using the collected indices and radiographs. The patients were split into two groups: those with peri-implant mucositis (136 implants) and those with peri-implant health (136 implants). We investigated the relationships between each parameter and periodontal health.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-implant mucositis | – | Other: ImplantIn the absence of bone loss, peri-implant mucositis refers to inflammation of the mucosa surrounding endosseous tissue |
| Periodontal health | – | Other: ImplantPeri-implant health is characterized by the absence of erythema, bleeding on probing, swelling, and suppuration, and is synonymous with implant success |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received implants
Key inclusion criteria (1 listed)
- Patients aged 18-65 years who were systemically healthy, had a controlled medical conditions, and had fixed prostheses on the implants for at least 1 year following functional prosthetic loading of the dental implants.
Key exclusion criteria (1 listed)
- Individuals with bruxism; those who smoke, were pregnant, or were breastfeeding; those who used anti-inflammatory drugs, immunosuppressants, or medications affecting the mucosa and bone; those who had undergone peri-implant disease treatment after implant placement; and those with residual cement residue and peri-implantitis related to prosthesis design or incorrectly placed implants.
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 |
|---|---|---|
| ImplantThe classification of peri-implant diseases is based on clinical and radiographic criteria, distinguishing between peri-implant mucositis and peri-implantitis according to the presence of inflammation and bone loss. | Other | Peri-implant mucositis, Periodontal health |
Primary outcome
Gingival phenotype
Time frame: Baseline
If the probe was visible when placed in the sulcus, gingiva was classified as thin (≤1 mm), and if the reflection of the probe was not visible, it was classified as thick (> 1 mm).
8 secondary outcomes
Periodontal pocket depth
Time frame: Baseline
Bleeding on probing
Time frame: Baseline
Plaque index
Time frame: Baseline
Gingival index
Time frame: Baseline
Clinical attachment level
Time frame: Baseline
Gingival recession
Time frame: Baseline
Gingival thickness
Time frame: Baseline
Keratinized tissue width
Time frame: Baseline
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 4 May 2026.
- 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.
TUGBA SAHIN principal investigator
Abant Izzet Baysal University
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 Peri Implant Mucositis, run by Tuğba ŞAHİN 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 1 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 4 May 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?
Gingival phenotype (time frame: Baseline). 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 4 May 2026.