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Recruiting NCT06514677

Non-Surgical Treatment of Peri-Implantitis With Ultrasonic Carbon Tip

No phase Interventional Peri-Implantitis Alveolar Bone Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasonic Carbon Tip, Titanium Curette.
Who it may be relevant to
Registry conditions: Peri-Implantitis, Alveolar Bone Loss. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparison of Two Different Mechanical Interventions in Non-Surgical Peri-implantitis Treatment

Overview

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.

Interventions

  • Procedure Ultrasonic Carbon Tip
    Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment
  • Procedure Titanium Curette
    Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Primary outcome measures

  • Periodontal depth decrease [Time frame: Baseline to 12th month]
Secondary outcome measures (1)
  • marginal bone level changes [Time frame: Baseline to 12th month]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology — Kütahya

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. PMID 37143407
  • 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. PMID 25496020
  • 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. PMID 33174712
  • 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. PMID 31123873

Identifiers

NCT: NCT06514677 · 2023-13/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗