Clinical trial NCT06998160: Analysis of the Factors Influencing the Occurrence of Peri-implant Inflammation in Patients With Oral Implant Repair and Study on the Maintenance Effect of Subgingival Sandblasting
Official title: Changsha Stomatological Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implantitis
Dental Implant Complications
Periodontal Inflammation
Gingival Diseases
Lead sponsor: Changsha Stomatological Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-31
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Abstract Objective The purpose of this study was to analyze the factors affecting the occurrence of peri-implant inflammation in patients with oral implant repair, and to explore the effect of subgingival sandblasting technology on the maintenance of microecology around the implant, so as to provide a basis for optimizing clinical prevention and treatment strategies.

Method Ninety-six patients with early periimplantitis treated in our hospital from July 2022 to July 2024 were selected as the inflammation group. All patients were randomly divided into control group, glycine subgingival sandblasting group and erythritol subgingival sandblasting group (n=32). The clinical therapeutic effect of the two groups was compared. A total of 102 patients who underwent oral implant repair in our hospital during the same period without peri-implant inflammation were selected as the group without inflammation. The independent risk factors of peri-implant inflammation were analyzed.


Eligibility criteria: Inclusion Criteria Clinical diagnosis of peri-implantitis (PD ≥4 mm with BOP/suppuration)

At least one functional dental implant in place for ≥6 months

Willing and able to maintain standard oral hygiene protocol

No antibiotic or anti-inflammatory drug use in the past 30 days

Absence of uncontrolled systemic diseases (e.g., diabetes, hypertension)

Complete baseline clinical data available (medical history, radiographs, lab results)

Exclusion Criteria Acute oral infections requiring immediate treatment

History of radiation therapy to the head/neck region

Severe uncontrolled periodontal disease

Active malignancy or current cancer treatment

Coagulation disorders or anticoagulant therapy

Pregnancy or lactation

Cognitive impairment affecting compliance

Allergy to glycine or erythritol compounds

Non-Inflammatory Group Additional Criteria Successful implant placement with no signs of inflammation (PD ≤3 mm, no BOP)

Matched to study group by age (±5 years) and implant location

Meets all other inclusion/exclusion criteria regarding systemic health

Note: All participants must provide informed consent. Healthy volunteers without implants are not eligible.

Primary outcomes:
measure: Change in Plaque Index (PLI) Score
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Bleeding Index (BI) Score
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Probing Depth (PD)
timeFrame: Baseline, 3 months, 6 months.
Secondary outcomes:
measure: Inflammatory Biomarker Levels (IL-6, IL-1β)
timeFrame: Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment
Other outcomes:
measure: Peri-Implantitis Recurrence Rate
timeFrame: 12 months post-treatment
Locations:
city: Changsha
country: China
facility: Changsha Stomatological Hospital
Study officials:
References: