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Impact of Glycine Therapy on Peri-implant Mucositis

Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05810558
Enrollment
30
Registered
2023-04-12
Start date
2016-06-16
Completion date
2020-12-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

Brief 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).

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

Interventions

PROCEDUREglycine powder air-powered debridement

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.

The control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
gingival inflammation6 monthspresence of redness, bleeding on gentle probing from the peri-implant sulcus

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026