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CompletedNCT06998160Updated May 31, 2025

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

An interventional study of glycine subgingival sandblasting group and erythritol subgingival sandblasting group and control group in Peri-implantitis, Dental Implant Complications and Periodontal Inflammation, sponsored by Hui Xie. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Hui Xie · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jul 2022, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Peri-implantitis
  • Dental Implant Complications
  • Periodontal Inflammation
  • Gingival Diseases
03

In context

Peri-Implantitis

313 studies on the registry are indexed under Peri-Implantitis; 85 are open to participants now.

This study's enrollment of 96 is above the median of 40 across 191 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

This is the only study on the registry with Hui Xie as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherglycine 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.

  • Othercontrol 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 months, 6 months.

  2. 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.

    Time frame: Baseline, 3 months, 6 months.

  3. 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.

    Time frame: Baseline, 3 months, 6 months.

Secondary outcomes

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

    Change in pro-inflammatory cytokine levels measured in peri-implant crevicular fluid via ELISA across treatment groups.

    Time frame: Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment

Other outcomes

  1. Peri-Implantitis Recurrence Rate

    Incidence of peri-implant inflammation recurrence (PD ≥5mm with bleeding/suppuration) in treated patients.

    Time frame: 12 months post-treatment

07

Study locations

1 site
  • Changsha Stomatological Hospital
    Changsha, China
08

References and documents

Publications

  • Pan T, Meng W, Zhang M, Xie Y, Chen Z, Zhou M, Yin L, Xie H. Analysis of the factors influencing the occurrence of peri-implantitis in patients with implant-supported restoration and study on the maintenance effect of subgingival sandblasting. BMC Oral Health. 2025 Oct 6;25(1):1541. doi: 10.1186/s12903-025-06945-9. PubMed 41053709 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06998160
Lead sponsor
Hui Xie
Responsible party
Hui Xie (Principal Investigator, Changsha Stomatological Hospital) — Sponsor-investigator
First posted
May 31, 2025
Start date
Jul 5, 2022
Primary completion
Mar 9, 2024
Completion
Jul 5, 2024
Last update
May 31, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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