Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

Terminated

• Conditions: Peri-Implantitis
• Interventions: Other: Observation

• Registration Number: NCT03772652
• Lead Sponsor: University of Michigan

Brief Summary

This study focuses on evaluating the success of different treatment methods for peri-implantitis (gum disease around implants) and to understand the factors that might affect the success of the treatment provided.

Detailed Description

Qualifying patients will be asked to participate in clinical measurements to compare the long-term success of their treatments.

The aims of the current study are to 1) assess the long-term outcome of the surgical treatment of peri-implantitis and to 2) evaluate the success of the different treatment modalities of peri-implantitis.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. The patient is at least 18 years of age,
2. was initially diagnosed with peri-implantitis at ≥1 implant (peri-implant probing depth (PPD) ≥ 6 mm together with bleeding and/or suppuration on probing (BOP/SoP) and radiologically assessed marginal bone loss ≥ 3 mm),
3. had received treatment for peri-implantitis at least 5 years ago at the Graduate Clinic of Periodontics at University of Michigan, and
4. documentation from ≥ 5 years of clinical and radiological follow-up is available from U of M patients records.

Exclusion Criteria

1. Has received or is currently receiving radiotherapy,
2. are currently pregnant, unsure of their pregnancy status, or are lactating (as reported by the patient),
3. has health condition(s) or takes medication(s) that are known to affect soft tissue or bone (e.g., Phenytoin)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peri-implantitis	Observation	Subjects who were diagnosed with peri-implantitis and received treatment at least five years ago at the Graduate Periodontics Clinic at University of Michigan with sufficient baseline data. Soft tissue measurements (observation) of the implant will be completed.

Primary Outcome Measures

Name	Time	Method
Therapeutic resolution of the peri-implantitis as measured by probing depths	At least five years after the implant was treated for peri-implantitis	The implant has probing depths less than or equal to 5 millimeters.
Survival rate of the peri-implantitis treated dental implants	At least five years after the implant was treated for peri-implantitis	Survival rate will be determined by the duration of implant survival (functioning, non-symptomatic implant after peri-implantitis treatment).
Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss	At least five years after the implant was treated for peri-implantitis	The implant has no further radiographic bone loss when compared to previous radiographs.
Therapeutic resolution of the peri-implantitis as measured by erythema	At least five years after the implant was treated for peri-implantitis	The implant has no current erythema of the peri-implant mucosa.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States