Peri-implantitis Implantoplasty Treatment

Peri-Implantitis Clinical Trial

Official title:

Surgical Peri-implantitis Treatment With and Without Implantoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04052373
• Other study ID #: IMPLANTOPLASTY
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: June 15, 2027

Study information

• Verified date: November 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis. Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 15, 2027
• Est. primary completion date: June 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
• Competent to give consent
• Exposed, modified implant surface with loss >2mm

Exclusion Criteria:

• Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
• Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
• Patients classified as > class II according to ASA classification
• Implant unavailable for implantoplasty treatment
• Inhability to comprehend and respond to the quality of life questionnaire
• Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
• History of peri-implantitis surgery prior to 6 months of screening

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

Intervention

Procedure:
• Implantoplasty
Implantoplasty is the mechanical smoothening of rough titanium implants as part of the surgical treatment of peri-implantitis. Treatment is thought to facilitate self-performed oral hygiene.
• Open flap debridement alone
Open flap debridement alone

Locations

Country	Name	City	State
Norway	Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo	Oslo
Norway	Institute of Clinical Dentistry, University of Oslo, Norway	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing	Measured with a periodontal probe	12 months after treatment
Primary	Bleeding on probing	Measured with a periodontal probe	24 months after treatment
Secondary	Suppuration	Visible suppuration upon probing the implant with a periodontal probe	12 months after treatment
Secondary	Suppuration	Visible suppuration upon probing the implant with a periodontal probe	24 months after treatment
Secondary	Pocket probing depth	Measured with a periodontal probe	12 months after treatment
Secondary	Pocket probing depth	Measured with a periodontal probe	24 months after treatment
Secondary	Changes in patient-reported quality of life (QoL)	To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome.; Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1)	Preoperatively compared to 24 months after treatment
Secondary	Clinical attachment loss measurements	Measured with a periodontal probe	12 months after treatment
Secondary	Clinical attachment loss measurements	Measured with a periodontal probe	24 months after treatment
Secondary	Radiographic bone loss	Measured on standardized radiograps	12 months after treatment
Secondary	Radiographic bone loss	Measured on standardized radiograps	24 months after treatment
Secondary	Implant fracture	Clinical examination to assess whether implants have fractured following treatment	24 months