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

NCT06998160 | Completed

• 1 other identifier: No. 2023-023
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implantitis; Dental Implant Complications; Periodontal Inflammation; Gingival Diseases

Outcome Measures

Primary Outcomes (3)

• Change in Plaque Index (PLI) Score

  Change in Plaque Index (PLI; scored 0-3) from baseline to 3 and 6 months post-treatment, comparing subgingival sandblasting (glycine/erythritol) versus standard ultrasonic curettage. Higher scores indicate greater plaque accumulation.

  Baseline, 3 months, 6 months.

• Change in Bleeding Index (BI) Score

  Change in Bleeding Index (BI; scored 0-3) from baseline to 3 and 6 months post-treatment, comparing interventions. Higher scores indicate more severe gingival bleeding.

  Baseline, 3 months, 6 months.

• Change in Probing Depth (PD)

  Change in Probing Depth (PD; measured in millimeters) from baseline to 3 and 6 months post-treatment, comparing interventions. Deeper pockets indicate worse peri-implant inflammation.

  Baseline, 3 months, 6 months.

Secondary Outcomes (1)

• Inflammatory Biomarker Levels (IL-6, IL-1β)

  Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment

Other Outcomes (1)

• Peri-Implantitis Recurrence Rate

  12 months post-treatment

Study Arms (2)

control group

OTHER

The control group was given ultrasonic subgingival curettage. With Swiss EMS ultrasonic therapy instrument, both the operator and the patient should wear safety goggles before operation. After the operator guides the patient to gargle, the mouth opener should be placed to perform ultrasonic subgingival curetting. The debridement time of the implant area should be controlled within 6 minutes, and the debridement time of other sites should be 5 s.

Other: control group

glycine subgingival sandblasting group and erythritol subgingival sandblasting group

OTHER

Given glycine subgingival sandblasting group glycine subgingival sandblasting group. Swiss EMS ultrasonic therapy instrument and EMS glycine sandblasting were used. Before the operation, both parties should wear safety glasses and place the mouth opener after the patient gargled. The location of sandblasting was selected to be 1-2 mm below the gingiva. During the operation, the time of sandblasting in the planting area should be controlled within 10 minutes, and then the time of sandblasting at other sites with the same amount of water and power should be controlled within 5s. After sandblasting, the patient's mouth was continuously rinsed with normal saline for 20s. After the operation, the patient was informed of the precautions after the operation, and the patient was instructed to master the correct oral maintenance method, pay attention to maintaining the cleanliness around the implant, and adhere to regular periodontal maintenance.

Other: glycine subgingival sandblasting group and erythritol subgingival sandblasting group

Interventions

glycine subgingival sandblasting group and erythritol subgingival sandblasting group OTHER

Given glycine subgingival sandblasting group glycine subgingival sandblasting group. Swiss EMS ultrasonic therapy instrument and EMS glycine sandblasting were used. Before the operation, both parties should wear safety glasses and place the mouth opener after the patient gargled. The location of sandblasting was selected to be 1-2 mm below the gingiva. During the operation, the time of sandblasting in the planting area should be controlled within 10 minutes, and then the time of sandblasting at other sites with the same amount of water and power should be controlled within 5s. After sandblasting, the patient's mouth was continuously rinsed with normal saline for 20s. After the operation, the patient was informed of the precautions after the operation, and the patient was instructed to master the correct oral maintenance method, pay attention to maintaining the cleanliness around the implant, and adhere to regular periodontal maintenance.

glycine subgingival sandblasting group and erythritol subgingival sandblasting group

control group OTHER

The control group was given ultrasonic subgingival curettage. With Swiss EMS ultrasonic therapy instrument, both the operator and the patient should wear safety goggles before operation. After the operator guides the patient to gargle, the mouth opener should be placed to perform ultrasonic subgingival curetting. The debridement time of the implant area should be controlled within 6 minutes, and the debridement time of other sites should be 5 s.

control group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hui Xie: lead

Study Sites (1)

Changsha Stomatological Hospital

Changsha, China

Location

MeSH Terms

Conditions

Peri-Implantitis; Gingival Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 31, 2025
• Study Start: July 5, 2022
• Primary Completion: March 9, 2024
• Study Completion: July 5, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-04

Locations

CN (1)