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

NCT06514677 | Recruiting

• 1 other identifier: 2023-13/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Periodontal depth decrease

  Periodontal pocket depth (PD) decreasing baseline to 12th month

  Baseline to 12th month

Secondary Outcomes (1)

• marginal bone level changes

  Baseline to 12th month

Study Arms (2)

Ultrasonic Carbon

EXPERIMENTAL

Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment

Procedure: Ultrasonic Carbon Tip

Titanium

ACTIVE COMPARATOR

Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Procedure: Titanium Curette

Interventions

Ultrasonic Carbon Tip PROCEDURE

Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment

Ultrasonic Carbon

Titanium Curette PROCEDURE

Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Titanium

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Central Study Contacts

Berceste Guler Ayyildiz, d

CONTACT

+90 (274) 260 00 43; berceste.guler@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For Outcomes Assessor Masking, Groups were not defined and anonymized and assessor will be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Group I: Using Ultrasonic Carbon Tip for Non-surgical Peri-implantitis Treatment Group II: Using Titanium Curettes for for Non-surgical Peri-implantitis Treatment

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 23, 2024
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)