Peri-implantitisNCT06998160
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
A study testing glycine subgingival sandblasting group and erythritol subgingival sandblasting group in people with Peri-implantitis and Dental Implant Complications, run by Hui Xie at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-implantitis, Dental Implant Complications, Periodontal Inflammation
- What is being tested?
- glycine subgingival sandblasting group and erythritol subgingival sandblasting group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2022to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peri-implantitis, Dental Implant Complications, Periodontal Inflammation, Gingival Diseases
- Being tested
- glycine subgingival sandblasting group and erythritol subgingival sandblasting group, control group
- Medical subject headings
- Peri-Implantitis, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycine subgingival sandblasting group and erythritol subgingival sandblasting groupOther
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.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: glycine subgingival sandblasting group and erythritol subgingival sandblasting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start5 Jul 2022
- Primary completion9 Mar 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui Xie
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hui Xie, Changsha Stomatological Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998160
- Sponsor's protocol ID
- No. 2023-023
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changsha Stomatological Hospital
- ClinicalTrials.gov ID
- NCT06998160
- Acronym / sponsor ID
- No. 2023-023
- Conditions
- Peri-implantitis, Dental Implant Complications, Periodontal Inflammation, Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hui XieOther government
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 9 Mar 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: control groupThe 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 | Other | Other: glycine subgingival sandblasting group and erythritol subgingival sandblasting groupGiven 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glycine subgingival sandblasting group and erythritol subgingival sandblasting groupGiven 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 |
| control groupThe 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 |
Primary outcome
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.
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.
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.
1 secondary outcome
Inflammatory Biomarker Levels (IL-6, IL-1β)
Time frame: Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 41053709Pan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glycine subgingival sandblasting group and erythritol subgingival sandblasting group in people with Peri-implantitis and Dental Implant Complications, run by Hui Xie at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index (PLI) Score (time frame: Baseline, 3 months, 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06998160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.