Clinical trial NCT06514677: Non-Surgical Treatment of Peri-Implantitis With Ultrasonic Carbon Tip
Official title: A Comparison of Two Different Mechanical Interventions in Non-Surgical Peri-implantitis Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Alveolar Bone Loss
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

1. Adult patients (≥18 years old)
2. Systemically healthy (ASA class 1 and ASA class 2)
3. Full-mouth plaque scores ≤20%
4. Implant had been in function for more than 6 months
5. Absence of plaque around the implant
6. Consent to complete all follow-up visits

Exclusion criteria:

1. Mobile implant
2. Overhanging restorations that prevent access to the implant for clinical measurements
3. Unresolvable technical complications that can cause peri-implantitis
4. Presence of active periodontal disease
5. Implants with a history of peri-implantitis treated using graft materials
6. Use of drugs that cause gingival hyperplasia
7. Systemic antibiotic use in the last 3 months
8. Acute and chronic medical conditions that prevent the patient from participating in the study
9. Presence of uncontrolled severe peri-implantitis from neighbouring implants
10. History of radiotherapy in the head and neck region
11. Receiving acute chemotherapy
12. Current corticosteroid therapy

Primary outcomes:
measure: Periodontal depth decrease
timeFrame: Baseline to 12th month
Secondary outcomes:
measure: marginal bone level changes
timeFrame: Baseline to 12th month
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Study officials:
References:
citation: 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.
citation: Blasi 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.
citation: Mensi 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.
citation: Nart 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.