Back to resultsExperimental Peri-implant Mucositis in Humans
Primary Purpose
Peri-implant Mucositis, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interruption of oral hygiene
Sponsored by
About this trial
This is an interventional supportive care trial for Peri-implant Mucositis
Eligibility Criteria
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.
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peri-implant mucosa
periodontal mucosa
Arm Description
Outcomes
Primary Outcome Measures
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks
The gingival crevicular fluid ( GCF) volume is assessed using Periotron unit. The GCF volume is strongly correlated with peri-implant mucosa and gingival inflammation.
Secondary Outcome Measures
Full Information
NCT ID
NCT01941797
First Posted
September 10, 2013
Last Updated
April 24, 2017
Sponsor
UConn Health
Collaborators
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT01941797
Brief Title
Experimental Peri-implant Mucositis in Humans
Official Title
Experimental Peri-implant Mucositis in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis, Gingivitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peri-implant mucosa
Arm Type
Experimental
Arm Title
periodontal mucosa
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
interruption of oral hygiene
Primary Outcome Measure Information:
Title
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks
Description
The gingival crevicular fluid ( GCF) volume is assessed using Periotron unit. The GCF volume is strongly correlated with peri-implant mucosa and gingival inflammation.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Experimental Peri-implant Mucositis in Humans
We'll reach out to this number within 24 hrs