Impact of Glycine Therapy on Peri-implant Mucositis

The Ohio State University

Status: Completed

Conditions: Peri-implant Mucositis

Treatments: Procedure: Ultrasonic instrumentation; Procedure: glycine powder air-powered debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT05810558

2016H0397

Details and patient eligibility

About

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).

Full 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

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups, including a placebo group

Arm 1 Ultrasonic

Placebo Comparator group

Description:

Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation

Treatment:

Procedure: Ultrasonic instrumentation

Arm 2 Glycine

Experimental group

Description:

Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement

Treatment:

Procedure: glycine powder air-powered debridement