The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy

NCT03421717 | Completed

• 1 other identifier: Peri-implantitis
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation and to arrest the progression of disease. It is important to systematically gather information on the effect of surgical peri-implant treatment and to assess different protocols regarding chair-side maintenance of peri-implant tissue after surgery The aims of this clinical investigation are to evaluate the clinical, microbiological and radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy on selected biochemical markers associated with chronic inflammation and bone tissue destruction.

Conditions

Periimplantitis; Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Inflammation control

  Absence/presence of bleeding on probing and deep peri-implant pockets

  3 months

Secondary Outcomes (1)

• Progressive bone loss

  3 months

Study Arms (2)

Test

EXPERIMENTAL

Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes

Device: Chitosan brush

Control

ACTIVE COMPARATOR

Treatment/maintenance of implants postsurgically performed by the use of titanium curettes

Device: Chitosan brush

Interventions

Chitosan brush DEVICE

If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation

Also known as: Titanium curettes

Control; Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Overt peri-implantitis presenting at least one implant with;
• radiographic bone loss ≥ 2.0 mm
• bleeding on probing (BoP)

You may not qualify if:

• radiotherapy
• chemotherapy
• systemic long-term corticosteroid treatment
• pregnancy or nursing
• anatomical abnormalities
• history of previous treatment of peri-implantitis within 6 months after the screening
• American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery \> 2

Sponsors & Collaborators

• University of Oslo: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Odd Carsten Koldsland, Ph.D

  Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Maintenance treatment (test/control) was performed after the investigator left the room. Investigator did not have access to the registration forms where information regarding assignment (test/control) was noted
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 6 month after surgical intervention, the population is randomly assigned to two parallel groups, receiving one of two maintenance programs - use of titanium curettes or chitosan brushes. Randomization was performed by pulling notes test/control.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: November 1, 2012
• Primary Completion: December 9, 2016
• Study Completion: April 28, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share