Peri-implant MucositisNCT05810558
Impact of Glycine Therapy on Peri-implant Mucositis
A study testing glycine powder air-powered debridement and Ultrasonic instrumentation in people with Peri-implant Mucositis, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the impact of glycine powder air-abrasive debridement (GPAD) on the microbiology of the tissues surrounding dental implants with health and inflammation (peri-implant mucositis). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- glycine powder air-powered debridement and Ultrasonic instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2016to 30 Dec 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Must have >1 tooth-borne, non-splinted single dental implant
- Signs of healthy dental implants (pocket probing depth <4mm and a lack of bleeding upon probing at peri-implant site) OR
- Signs of peri-implant mucositis (> 4mm probing pocket depths at the dental implant site, bleeding upon probing at >1 peri-implant site, pre-brushing plaque score of > 1.9 (modified Plaque Index (mPI)), and radiographic evidence of bone loss less than 2mm).
Who cannot join
- Uncontrolled medical condition (i.e. Diabetes, History of smoking <5 years)
- Pregnant or lactating females
- Untreated periodontal conditions
- Use of antibiotics in the past 3 months
- Subjects treated with medication for >2 weeks with known effects to the oral tissues (i.e. coumadin, phenytoin, nifedipine, cyclosporine, non-steroidal anti-inflammatory drugs)
- Signs of peri-implantitis (pocket probing depth of 4-6mm with bleeding upon probing at >1 peri-implant site AND radiographic bone loss)
- Dental implant mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis
The purpose of this research study is to determine the impact of glycine powder air-abrasive debridement (GPAD) on the microbiology of the tissues surrounding dental implants with health and inflammation (peri-implant mucositis).
Read the detailed description
Peri-implant mucositis, or the infection of the gingival tissues surrounding a dental implant, and peri-implantitis, or the infection of the gingival tissue surrounding a dental implant with bone loss, can lead to the failure and eventual loss of dental implants. The prevalence of peri-implant mucositis ranges from 30.7-43% and the prevalence of peri-implantitis ranges from 9.6-22% with non-smokers. Traditional treatment of this disease has been through biofilm removal using ultrasonic instrumentation. Glycine is a non-essential amino acid that possesses an anti-inflammatory, immunomodulary, and a cytoprotective effect. The goal of this investigation is to examine the impact of glycine-augmented biofilm removal on resolution of peri-implant mucositis
- Conditions
- Peri-implant Mucositis
- Being tested
- glycine powder air-powered debridement, Ultrasonic instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycine powder air-powered debridementProcedure or surgery
The intervention treatment consist sof glycine powder air-abrasive debridement (GPAD) using a handheld air polishing device, disposable subgingival nozzle, and glycine powder The nozzle is inserted to the depth of the pocket and all surfaces of the implant (mesial, buccal, distal, lingual) debrided for 5 seconds.
Ultrasonic instrumentationProcedure or surgery
The control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Ultrasonic | Placebo comparator | Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation Receives: Procedure: Ultrasonic instrumentation |
| Arm 2 Glycine | Experimental | Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement Receives: Procedure: glycine powder air-powered debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival inflammation
presence of redness, bleeding on gentle probing from the peri-implant sulcus
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start16 Jun 2016
- Primary completion30 Sep 2017
- Study completion30 Dec 2020
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-implant MucositisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Purnima S Kumar, DDS, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810558
- Sponsor's protocol ID
- 2016H0397
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Partido B, Saraswat S, Kumar PS. Impact of Glycine Powder Air-Abrasive Debridement on Peri-Implant Mucositis: A Randomized Control Trial of Clinical, Microbial, and Immunological Changes. Clin Oral Implants Res. 2025 Jan;36(1):82-91. doi: 10.1111/clr.14361. Epub 2024 Sep 28.
PubMed 39340233
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis
- ClinicalTrials.gov ID
- NCT05810558
- Acronym / sponsor ID
- 2016H0397
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 12 Apr 2023 (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.
The purpose of this research study is to determine the impact of glycine powder air-abrasive debridement (GPAD) on the microbiology of the tissues surrounding dental implants with health and inflammation (peri-implant mucositis).
Detailed description
Peri-implant mucositis, or the infection of the gingival tissues surrounding a dental implant, and peri-implantitis, or the infection of the gingival tissue surrounding a dental implant with bone loss, can lead to the failure and eventual loss of dental implants. The prevalence of peri-implant mucositis ranges from 30.7-43% and the prevalence of peri-implantitis ranges from 9.6-22% with non-smokers. Traditional treatment of this disease has been through biofilm removal using ultrasonic instrumentation. Glycine is a non-essential amino acid that possesses an anti-inflammatory, immunomodulary, and a cytoprotective effect. The goal of this investigation is to examine the impact of glycine-augmented biofilm removal on resolution of peri-implant mucositis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Ultrasonic | Placebo comparator | Procedure: Ultrasonic instrumentationSubjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation |
| Arm 2 Glycine | Experimental | Procedure: glycine powder air-powered debridementSubjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Must have >1 tooth-borne, non-splinted single dental implant
- Signs of healthy dental implants (pocket probing depth <4mm and a lack of bleeding upon probing at peri-implant site) OR
- Signs of peri-implant mucositis (> 4mm probing pocket depths at the dental implant site, bleeding upon probing at >1 peri-implant site, pre-brushing plaque score of > 1.9 (modified Plaque Index (mPI)), and radiographic evidence of bone loss less than 2mm).
Key exclusion criteria (7 listed)
- Uncontrolled medical condition (i.e. Diabetes, History of smoking <5 years)
- Pregnant or lactating females
- Untreated periodontal conditions
- Use of antibiotics in the past 3 months
- Subjects treated with medication for >2 weeks with known effects to the oral tissues (i.e. coumadin, phenytoin, nifedipine, cyclosporine, non-steroidal anti-inflammatory drugs)
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 powder air-powered debridementThe intervention treatment consist sof glycine powder air-abrasive debridement (GPAD) using a handheld air polishing device, disposable subgingival nozzle, and glycine powder The nozzle is inserted to the depth of the pocket and all surfaces of the implant (mesial, buccal, distal, lingual) debrided for 5 seconds. | Procedure or surgery | Arm 2 Glycine |
| Ultrasonic instrumentationThe control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste | Procedure or surgery | Arm 1 Ultrasonic |
Primary outcome
gingival inflammation
Time frame: 6 months
presence of redness, bleeding on gentle probing from the peri-implant sulcus
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 12 Apr 2023.
- Derived from this study: PubMed 39340233Partido B, Saraswat S, Kumar PS. Impact of Glycine Powder Air-Abrasive Debridement on Peri-Implant Mucositis: A Randomized Control Trial of Clinical, Microbial, and Immunological Changes. Clin Oral Implants Res. 2025 Jan;36(1):82-91. doi: 10.1111/clr.14361. Epub 2024 Sep 28.
- Individual participant dataSharing planned: No
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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.
Purnima S Kumar, DDS, PhD principal investigator
Ohio State University
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 powder air-powered debridement and Ultrasonic instrumentation in people with Peri-implant Mucositis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
gingival inflammation (time frame: 6 months). 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 NCT05810558, 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 12 Apr 2023.