Peri-ImplantitisNCT06514677
Non-Surgical Treatment of Peri-Implantitis With Ultrasonic Carbon Tip
A study testing Ultrasonic Carbon Tip and Titanium Curette in people with Peri-Implantitis and Alveolar Bone Loss, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Alveolar Bone Loss
- What is being tested?
- Ultrasonic Carbon Tip and Titanium Curette
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old)
- Systemically healthy (ASA class 1 and ASA class 2)
- Full-mouth plaque scores ≤20%
- Implant had been in function for more than 6 months
- Absence of plaque around the implant
- Consent to complete all follow-up visits
Who cannot join
- Mobile implant
- Overhanging restorations that prevent access to the implant for clinical measurements
- Unresolvable technical complications that can cause peri-implantitis
- Presence of active periodontal disease
- Implants with a history of peri-implantitis treated using graft materials
- Use of drugs that cause gingival hyperplasia
Show all 12Show fewer
- Systemic antibiotic use in the last 3 months
- Acute and chronic medical conditions that prevent the patient from participating in the study
- Presence of uncontrolled severe peri-implantitis from neighbouring implants
- History of radiotherapy in the head and neck region
- Receiving acute chemotherapy
- Current corticosteroid therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, 43100
Berceste Güler
About this study
Official title: A Comparison of Two Different Mechanical Interventions in Non-Surgical Peri-implantitis Treatment
As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Non-surgical treatment is the recommended treatment in the first stage due to its shorter duration and low morbidity rate. Non-surgical treatment of peri-implantitis provides clinical improvements such as reduced bleeding on probing (20-50%) and, in some cases, reduced pocket depth (≤ 1 mm). This study aims to clinically and radiographically compare two different mechanical treatments in patients with mild and moderate peri-implantitis.
Read the detailed description
60 patients with at least one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm will be randomly allocated to test and control groups, receiving titanium curettes or ultrasonic Carbon tips debridement, respectively. Treatment was performed at baseline. Plaque index (PI), gingival index (GI), Periodontal pocket depth (PD), Bleeding on probing (BOP) gingival recession (GR) and Clinical attachment level (CAL) will be measured at four sites per implant and recorded by examiner at baseline, one, three, six and twelve months. Pus will be recorded as present/not present. The radiographic marginal bone level changes will be calculated at baseline, third months, sixth months and 12 months.
- Conditions
- Peri-Implantitis, Alveolar Bone Loss
- Being tested
- Ultrasonic Carbon Tip, Titanium Curette
- Medical subject headings
- Peri-Implantitis, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Carbon TipProcedure or surgery
Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment
Titanium CuretteProcedure or surgery
Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Carbon | Experimental | Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment Receives: Procedure: Ultrasonic Carbon Tip |
| Titanium | Active comparator | Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment Receives: Procedure: Titanium Curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal depth decrease
Periodontal pocket depth (PD) decreasing baseline to 12th month
Measured: Baseline to 12th month
Secondary outcomes (1)
marginal bone level changes
Marginal bone level changes will be calculated at standardized periapical radiography
Measured: Baseline to 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Dec 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Model description
- Group I: Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment Group II: Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514677
- Sponsor's protocol ID
- 2023-13/01
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.
PubMed 37143407Blasi A, Iorio-Siciliano V, Pacenza C, Pomingi F, Matarasso S, Rasperini G. Biofilm removal from implants supported restoration using different instruments: a 6-month comparative multicenter clinical study. Clin Oral Implants Res. 2016 Feb;27(2):e68-73. doi: 10.1111/clr.12530. Epub 2014 Dec 11.
PubMed 25496020Mensi M, Viviani L, Agosti R, Scotti E, Garzetti G, Calza S. Comparison between four different implant surface debridement methods: an in-vitro experimental study. Minerva Stomatol. 2020 Oct;69(5):286-294. doi: 10.23736/S0026-4970.20.04342-3.
PubMed 33174712Nart J, Pons R, Valles C, Esmatges A, Sanz-Martin I, Monje A. Non-surgical therapeutic outcomes of peri-implantitis: 12-month results. Clin Oral Investig. 2020 Feb;24(2):675-682. doi: 10.1007/s00784-019-02943-8. Epub 2019 May 23.
PubMed 31123873
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Mechanical Interventions in Non-Surgical Peri-implantitis Treatment
- ClinicalTrials.gov ID
- NCT06514677
- Acronym / sponsor ID
- 2023-13/01
- Conditions
- Peri-Implantitis, Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Non-surgical treatment is the recommended treatment in the first stage due to its shorter duration and low morbidity rate. Non-surgical treatment of peri-implantitis provides clinical improvements such as reduced bleeding on probing (20-50%) and, in some cases, reduced pocket depth (≤ 1 mm). This study aims to clinically and radiographically compare two different mechanical treatments in patients with mild and moderate peri-implantitis.
Detailed description
60 patients with at least one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm will be randomly allocated to test and control groups, receiving titanium curettes or ultrasonic Carbon tips debridement, respectively. Treatment was performed at baseline. Plaque index (PI), gingival index (GI), Periodontal pocket depth (PD), Bleeding on probing (BOP) gingival recession (GR) and Clinical attachment level (CAL) will be measured at four sites per implant and recorded by examiner at baseline, one, three, six and twelve months. Pus will be recorded as present/not present. The radiographic marginal bone level changes will be calculated at baseline, third months, sixth months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group I: Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment Group II: Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Carbon | Experimental | Procedure: Ultrasonic Carbon TipUsing Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment |
| Titanium | Active comparator | Procedure: Titanium CuretteUsing Titanium Curettes for for Non-surgical Peri-implantitis Treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (≥18 years old)
- Systemically healthy (ASA class 1 and ASA class 2)
- Full-mouth plaque scores ≤20%
- Implant had been in function for more than 6 months
- Absence of plaque around the implant
Key exclusion criteria (12 listed)
- Mobile implant
- Overhanging restorations that prevent access to the implant for clinical measurements
- Unresolvable technical complications that can cause peri-implantitis
- Presence of active periodontal disease
- Implants with a history of peri-implantitis treated using graft materials
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 |
|---|---|---|
| Ultrasonic Carbon TipUsing Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment | Procedure or surgery | Ultrasonic Carbon |
| Titanium CuretteUsing Titanium Curettes for for Non-surgical Peri-implantitis Treatment | Procedure or surgery | Titanium |
Primary outcome
Periodontal depth decrease
Time frame: Baseline to 12th month
Periodontal pocket depth (PD) decreasing baseline to 12th month
1 secondary outcome
marginal bone level changes
Time frame: Baseline to 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 37143407Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.
- Background: PubMed 25496020Blasi A, Iorio-Siciliano V, Pacenza C, Pomingi F, Matarasso S, Rasperini G. Biofilm removal from implants supported restoration using different instruments: a 6-month comparative multicenter clinical study. Clin Oral Implants Res. 2016 Feb;27(2):e68-73. doi: 10.1111/clr.12530. Epub 2014 Dec 11.
- Background: PubMed 33174712Mensi M, Viviani L, Agosti R, Scotti E, Garzetti G, Calza S. Comparison between four different implant surface debridement methods: an in-vitro experimental study. Minerva Stomatol. 2020 Oct;69(5):286-294. doi: 10.23736/S0026-4970.20.04342-3.
- Background: PubMed 31123873Nart J, Pons R, Valles C, Esmatges A, Sanz-Martin I, Monje A. Non-surgical therapeutic outcomes of peri-implantitis: 12-month results. Clin Oral Investig. 2020 Feb;24(2):675-682. doi: 10.1007/s00784-019-02943-8. Epub 2019 May 23.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Carbon Tip and Titanium Curette in people with Peri-Implantitis and Alveolar Bone Loss, run by Kutahya Health Sciences 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berceste Guler Ayyildiz, d (+90 (274) 260 00 43, berceste.guler@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal depth decrease (time frame: Baseline to 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514677, which also lists 4 linked publications.
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 12 Mar 2025.