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

Completed

Conditions: infection of mucosa surrounding a dental implant
peri-implant mucositis
10004018

Registration Number: NL-OMON35044

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is bleeding on probing;</p><br>

Secondary Outcome Measures

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