Overview

This trial is active, not recruiting.

Conditions peri-implant mucositis, gingivitis
Treatment interruption of oral hygiene
Sponsor University of Connecticut Health Center
Collaborator Colgate Palmolive Co.
Start date September 2012
End date September 2014
Trial size 15 participants
Trial identifier NCT01941797, cro-2011perio-02-fp

Summary

This is a pilot study. The investigators hypothesize that the peri-implant soft tissue response to de novo plaque accumulation is similar to that of normal gingival tissue in the same subjects.

The investigators propose to conduct a controlled clinical trial to evaluate peri-implant soft tissue response to de novo plaque accumulation in comparison to the response of gingival tissue in the same subjects

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
interruption of oral hygiene
(Active Comparator)
interruption of oral hygiene

Primary Outcomes

Measure
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks
time frame: 9 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: -Male and Female ³21 years of age. Oral site specific inclusion criteria: - 1) Presence of 2 implants in the maxillary or mandibular arch supporting fixed restorations in function for at least 1 year (Test) - 2) Presence of 2 teeth in the corresponding position of the implant (Control); -3) Absence of active infections at both test and control sites - 4) Absence of radiographic bone loss at both test and control sites - 5) Pocket depth ≤4mm at both test and control sites - 6) must give written informed consent. Exclusion Criteria: - 1) Treatment with antibiotics for any dental or medical condition within 1 month before screening - 2) Systemic diseases that require chronic use of anti-inflammatory medications, antibiotics or anticoagulants - 3) Ongoing medications for systemic conditions initiated <3 months before the start of the study or the requirement to take prophylactic antibiotics for invasive dental procedures - 4) Significant organ disease including impaired kidney function, heart murmur, rheumatic fever, bleeding disorder - 5) Active infectious diseases such as hepatitis, tuberculosis and HIV - 6) Clinically detectable caries and periodontal disease - 7) Tobacco use of any kind - 8) Use of medications affecting periodontal status (diphenylhydantoin, cyclosporine etc.) - 9) No pregnancy or lactation or expectation to become pregnant within next 3 months. Participants will be excluded from the study or analysis if any of the following occur during the study: 1) Changes in the patient medical status or medications that met the exclusion criteria; 2) Use of antimicrobial rinses; 3) Use of irrigating devices; 4) Subject noncompliance with stent wearing during the experimental mucositis/gingivitis phase and/or Vitamin C use; 5) Use of anti-inflammatory drugs or antibiotics; 6) allergic history to common toothpaste or mouth rinse ingredients. Acute use of acetaminophen will be permitted.

Additional Information

Official title Experimental Peri-implant Mucositis in Humans
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Connecticut Health Center.