Implant Site Bleeding Clinical Trial
Official title:
A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants in Maintenance Patients: a Randomized Controlled Trial
| Verified date | April 2021 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study was to compare two different interproximal devices, water flosser and dental floss around implants in several clinical parameters
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | March 31, 2021 |
| Est. primary completion date | March 31, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients that present with at least a single implant with a screw-retained crown - Patients with general good health that do not have a condition contra-indicating routine dental treatment - Patients that are compliant with the research protocol and methods - Patients that have read, understood and signed the informed consent form Exclusion Criteria: - Patients with implants with cemented crowns - Patients with any contact hypersensitivity to the related materials used in the study - Tobacco users (vaping included) - Patients unwilling to sign the informed consent form or follow the protocol of the study |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Manitoba | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba |
Canada,
Kelekis-Cholakis A, Rothney J. Maintenance of Implant Patients: A Narrative Review. Implant Dent. 2019 Apr;28(2):161-172. doi: 10.1097/ID.0000000000000837. Review. — View Citation
Magnuson B, Harsono M, Stark PC, Lyle D, Kugel G, Perry R. Comparison of the effect of two interdental cleaning devices around implants on the reduction of bleeding: a 30-day randomized clinical trial. Compend Contin Educ Dent. 2013 Nov-Dec;34 Spec No 8:2-7. — View Citation
Montevecchi M, De Blasi V, Checchi L. Is Implant Flossing a Risk-Free Procedure? A Case Report with a 6-year Follow-up. Int J Oral Maxillofac Implants. 2016 May-Jun;31(3):e79-83. doi: 10.11607/jomi.4263. — View Citation
Testori T, Del Fabbro M, Feldman S, Vincenzi G, Sullivan D, Rossi R Jr, Anitua E, Bianchi F, Francetti L, Weinstein RL. A multicenter prospective evaluation of 2-months loaded Osseotite implants placed in the posterior jaws: 3-year follow-up results. Clin Oral Implants Res. 2002 Apr;13(2):154-61. — View Citation
van Velzen FJ, Lang NP, Schulten EA, Ten Bruggenkate CM. Dental floss as a possible risk for the development of peri-implant disease: an observational study of 10 cases. Clin Oral Implants Res. 2016 May;27(5):618-21. doi: 10.1111/clr.12650. Epub 2015 Aug 11. — View Citation
Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4:CD012018. doi: 10.1002/14651858.CD012018.pub2. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in BOP (bleeding on probing) index around dental implants | to determine the effectiveness of a waterfloss system compared to flossing in changing the bleeding on probing (BOP) index around dental implants. BOP is a sign of inflammation and is recorded as yes/no (yes for bleeding, no for absence of bleeding). BOP is a percentage calculated by dividing the number of bleeding sites divided by the total number of sites of each implant. A lower percentage indicates lower inflammation | All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months) | |
| Primary | Full Mouth Plaque Score (FMPS) | to determine the differences between water flosser compared to flossing in changing the Full Mouth Plaque Score (FMPS). FMPS is a percentage calculated by dividing the number of plaque containing surfaces divided by the total number of available surfaces of each tooth/implant. A lower percentage indicates lower total plaque and means better plaque control | All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months) | |
| Primary | Quigley-Hein plaque index (QHI) around dental implants | to determine the differences of a waterfloss system compared to flossing in (QHI) around dental implants. Quigley-Hein plaque index (QHI) is a scale 0 to 5.
0 no plaque. separate flecks of plaque at the cervical margin of the tooth. a thin continuous band of plaque (up to one mm) at the cervical margin of the tooth. a band of plaque wider than one mm but covering less than one-third of the crown of the tooth. plaque covering at least one-third but less than two-thirds of the crown of the tooth. plaque covering two-thirds or more of the crown of the tooth. A lower number indicates better plaque control. |
All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months) | |
| Primary | keratinized tissue (KT) around dental implants | to evaluate the differences of a waterfloss system compared to flossing in the width of keratinized tissue (KT) around dental implants. KT is the stratified, squamous epithelium, that lines the vestibular and oral surfaces of the gingiva. | All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months) | |
| Primary | Probing Depth (PD) around dental implants | to evaluate the differences of a waterfloss system compared to flossing in Probing Depth (PD) around dental implants. PD is the measurement of the depth of a sulcus by measuring in millimeters the distance from a gingival margin to the base of the sulcus with a calibrated periodontal probe. | All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months) |