Skip to content

Treatment of peri-implant mucositis; A randomized placebo controlled clinical study

Treatment of peri-implant mucositis; A randomized placebo controlled clinical study - Treatment of peri-implant mucositis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35044
Enrollment
30
Registered
2010-06-16
Start date
2010-07-02
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

infection of mucosa surrounding a dental implant peri-implant mucositis

Interventions

Implants with peri-implant mucositis will be cleaned mechanically both supra- and submucosal, using plastic scalers and curettes, rubber cups and polishing paste, followed by 4 weeks of mouthrinses

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) The patient is >=18 years of age; 2) The patient has at least one endosseous implant in the oral cavity with clinical signs of peri-implant mucositis. Peri-implant mucositis is defined as bleeding of the peri-implant mucosa on probing, with no signs of loss of supporting bone; 3) The implants have been exposed to the oral environment for at least one year; 4) The patient is capable of understanding and giving informed consent.

Exclusion criteria

Exclusion criteria: 1) Medical and general contraindications for the interventions; 2) A history of local radiotherapy to the head and neck region; 3) Diabetes; 4) Patients who are allergic to chlorhexidine; 5) Systemic use of antibiotics during the last 3 months; 6) Long-term use of anti-inflammatory drugs; 7) Incapability of performing basal oral hygiene measures as a result of physical or mental disorders; 8) Active, uncontrolled periodontal pathology of the remaining dentition. 9) Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 3 months; 10) Use of mouthrinses during the last 6 weeks or during the course of the study; 11) Implants placed in skin grafted areas; 12) Peri-implantitis; 13) Implant mobility; 14) Implants at which no surface can be identified where proper probing measurements can be performed; 15) Previous treatment of peri-implant mucositis lesions during the last 6 months.

Design outcomes

Primary

MeasureTime frame
The main study parameter is bleeding on probing;

Secondary

MeasureTime frame
- Modified bleeding index; - Probing pocket depth (PPD); - Modified plaque index; - Implant calculus index; - Marginal soft tissue recession (REC); - Width of keratinized epithelium; - Suppuration on probing; - Microbiological status of the peri-implant sulcus; - Radiographic marginal bone level on standardized intraoral radiographs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)