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

May 28, 2025 updated by: Hui Xie

Changsha Stomatological Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Changsha Stomatological Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
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
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: glycine subgingival sandblasting group and erythritol subgingival sandblasting group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plaque Index (PLI) Score
Time Frame: Baseline, 3 months, 6 months.
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
Time Frame: Baseline, 3 months, 6 months.
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)
Time Frame: Baseline, 3 months, 6 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Biomarker Levels (IL-6, IL-1β)
Time Frame: Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment
Change in pro-inflammatory cytokine levels measured in peri-implant crevicular fluid via ELISA across treatment groups.
Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-Implantitis Recurrence Rate
Time Frame: 12 months post-treatment
Incidence of peri-implant inflammation recurrence (PD ≥5mm with bleeding/suppuration) in treated patients.
12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Xie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2022

Primary Completion (Actual)

March 9, 2024

Study Completion (Actual)

July 5, 2024

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 28, 2025

First Posted (Actual)

May 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 2023-023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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