The primary objective of this controlled clinical study is to evaluate the effect of chlorhexidine + CPC rinsing of the oral cavity for treatment of peri-implant mucositis.The secondary objectives are to assess the effectiveness of peri-implant…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is bleeding on probing;
Secondary outcome
- 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.
Background summary
Peri-implant mucositis is an infectious disease that resides in the mucosa
surrounding dental implants. If left untreated peri-implant mucositis might
develop into peri-implantitis, an infectious disease residing in the mucosa
surrounding dental implants which also affects the supporting bone. The number
of implants placed in everyday clinical practice is continuously increasing,
and it is anticipated that the prevalence of peri-implant mucositis will
further increase. This underlines the necessity for a predictable therapy.
Scientific literature provides very little evidence for an effective
intervention protocol for treatment of peri-implant mucositis.
Study objective
The primary objective of this controlled clinical study is to evaluate the
effect of chlorhexidine + CPC rinsing of the oral cavity for treatment of
peri-implant mucositis.
The secondary objectives are to assess the effectiveness of peri-implant
mucositis treatment and to assess the microbiology associated with peri-implant
mucositis.
Study design
The present study is a double-blind, placebo-controlled, randomized clinical
trial.
Intervention
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 with a chlorhexidine solution (0.12%
chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®))
or a placebo solution twice daily during 30 seconds;
Study burden and risks
All data will be collected during regular follow-up visits (according to the
current umcg-protocol for treatment of peri-implant mucositis). Data collection
will consist of clinical measurements, microbiologisch sampling, a
questionnaire and digital intra-oral pictures.
Antonius Deusinglaan 1
9713 AV
NL
Antonius Deusinglaan 1
9713 AV
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31615.042.10 |