SPiT-frequency; the Effect of Increased Frequency of Intervention on Post-surgical Peri-implant Inflammation

NCT04705012 | Unknown

• 1 other identifier: 195347
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study is an interventional clinical study on the supportive peri-implant treatment (SPiT) necessary to maintain/ improve the clinical conditions surrounding a dental implant following surgical treatment of peri-implantitis. The focus of this pilot, double arm, split-mouth, single centre, controlled, randomised clinical study is to examine the effect of short-term increased frequency of a SPiT-protocol.

Conditions

Peri-Implantitis

Keywords

SPiT

Outcome Measures

Primary Outcomes (1)

• Eradication of disease

  Proportion of implants without signs of inflammation defined as BoP and/or suppuration (eradication of disease)

  9 months

Secondary Outcomes (4)

• Reduction in inflammation,

  9 months

• Radiographic changes

  9 months

• Morbidity, patient centered outcomes

  9 month

• Implant survival

  9 month

Study Arms (2)

Test - increased frequency of submucosal cleaning

EXPERIMENTAL

At follow-up time points (3-, 6-, 9-, 16 weeks) following initial treatment), all implants receive supramucosal polishing, but only test-implants receive submucosal debridement 12 + 24 +36 weeks following baseline: all implants receive supramucosal polishing as well as submucosal debridement as described above

Other: Submucosal supportive therapy

Control - conventional frequency of submucosal cleaning

ACTIVE COMPARATOR

At follow-up time points (3-, 6-, 9-, 16 weeks) following initial treatment), all implants receive supramucosal polishing, but only test-implants receive submucosal debridement 12 + 24 +36 weeks following baseline: all implants receive supramucosal polishing as well as submucosal debridement as described above

Other: Submucosal supportive therapy

Interventions

Submucosal supportive therapy OTHER

Increased frequency of submucosal cleaning using a rotating chitosan brush

Control - conventional frequency of submucosal cleaning; Test - increased frequency of submucosal cleaning

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥ 20 years,
• Subjects must have received surgical treatment of peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018).
• Subjects have to present inflammation (suppuration or BoP 3-2) at more than one implant of similar implant brand, with similar defect type (Schwarz et al., 2007), and defect severity.
• The implants must not be replacing adjacent teeth (minimum space for one tooth/implant between test and control.

You may not qualify if:

• Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.
• No pregnant or nursing subjects.
• \< class 2 according to the ASA (American Society of Anesthesiologists) physical status classification.
• Registered implant bone loss with exposed modified surface \< 2.0 mm.
• If examiners/operators agree the placement of the implant (angle, position, proximity to adjacent implant or tooth) or suprastructure was suboptimal and considered to play a major role in the development and sustain the peri-implant disease.
• Anatomical abnormalities
• specific concomitant treatment with other devise, mouthrinse or systemic antibiotics
• participation in any other clinical study within the last month
• inability to comprehend and respond to the quality of life questionnaire

Sponsors & Collaborators

• University of Oslo: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will not participate in the treatment, is blinded to what implant receives which treatment and leaves the room following examination prior to treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Examiner blinded split-mouth clinical trial

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 12, 2021
• Study Start: January 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-11