NCT02697539: PFR

"Efficacy of a New Carbonate/Hydroxyapatite Nanocrystal Dentifrice on the Dental Plaque Index and the de Novo Plaque Formation Rate in Individuals Suffering From Gingivitis and/or Periodontitis"

Completed NA Last updated 26 February 2016

What this trial tests

NA trial testing AmF/SnF2 in Chronic Periodontitis in 74 participants. Completed in 1 December 2011.

Timeline

1 March 2011

Primary endpoint
1 September 2011

1 December 2011

Quick facts

Lead sponsor	University Hospital Muenster
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	74
Start date	1 March 2011
Primary completion	1 September 2011
Estimated completion	1 December 2011

Drugs / interventions tested

• AmF/SnF2
• mHA — full drug profile →

Conditions studied

• Chronic Periodontitis — all drugs for Chronic Periodontitis →

Sponsor

University Hospital Muenster

Who can join

Adults 18 to 75, any sex, with Chronic Periodontitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary outcome plaque formation rate (PFR) was measured 24 hours after all teeth were treated mechanically.
  Time frame: Measured 24 hours after all teeth were treated mechanically .
  For the recording of PFR,all teeth were stained with a plaque revealer (Mira 2-Ton® Miradent, Hager \& Werken GmbH, Duisburg, Germany).

Sponsor's own description

This 12-week prospective, randomized, double-blind, two-center trial evaluated the impact of a microcrystalline zinc-hydroxyapatite (mHA) dentifrice on plaque formation rate (PFR) in periodontitis patients. The investigators hypothesized that mHA precipitates cause delayed plaque development when compared to a fluoridated control (AmF/SnF2), and therefore would improve periodontal health.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of the Daily Use of a Microcrystal Hydroxyapatite Dentifrice on De Novo Plaque Formation and Clinical/Microbiological Parameters of Periodontal Health. A Randomized Trial.
   Harks I, Jockel-Schneider Y, Schlagenhauf U, May TW, et al · · 2016 · cited 25× · PMID 27467683 · DOI 10.1371/journal.pone.0160142
2. No differences in microbiome changes between anti-adhesive and antibacterial ingredients in toothpastes during periodontal therapy.
   Hagenfeld D, Prior K, Harks I, Jockel-Schneider Y, et al · · 2019 · cited 21× · PMID 30851050 · DOI 10.1111/jre.12645