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

NCT ID: NCT06998160

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2024-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Peri-implantitis Dental Implant Complications Periodontal Inflammation Gingival Diseases

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

control group

Intervention Type 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.

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.

Group Type OTHER

glycine subgingival sandblasting group and erythritol subgingival sandblasting group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hui Xie

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hui Xie

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Changsha Stomatological Hospital

Changsha, , China

Site Status

Countries

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China

Other Identifiers

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No. 2023-023

Identifier Type: -

Identifier Source: org_study_id

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