NCT02697539

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 23, 2016

Last Update Submit

February 26, 2016

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Primary outcome plaque formation rate (PFR) was 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).

    Measured 24 hours after all teeth were treated mechanically .

Secondary Outcomes (5)

  • full mouth plaque control record (PCR, O'Leary 1972).

    at baseline (visit 2a), after 4 weeks and after 12 weeks

  • gingival index (GI, Löe 1967),

    at baseline (visit 2a), after 4 weeks and after 12 weeks

  • pocket probing depths (PPD)

    at baseline (visit 2a), after 4 weeks and after 12 weeks

  • bleeding on probing (BOP, Lang et al. 1990),

    at baseline (visit 2a), after 4 weeks and after 12 weeks

  • gingival recession (GR)

    at baseline (visit 2a), after 4 weeks and after 12 weeks

Study Arms (2)

AmF/SnF2 group

PLACEBO COMPARATOR

Patients in this arm were adviced to use a standart dentifrice over the course of the study (AmF/SnF2, Meridol®, GABA, Lörrach, Germany).

Other: mHA

mHA group

ACTIVE COMPARATOR

Patients in this arm were adviced to use the new dentifrice over the course of the study (mHA, BioRepair®, Wolff, Bielefeld, Germany).

Other: AmF/SnF2

Interventions

AmF/SnF2OTHER

AmF/SnF2 dentifrice used twice daily for 2 minutes for 12 weeks

Also known as: Meridol®, GABA, Lörrach, Germany
mHA group
mHAOTHER

microcrystalline zinc-hydroxyapatite (mHA) dentifrice dentifrice used twice daily for 2 minutes for 12 weeks.

Also known as: BioRepair® toothpaste, Kurt Wolff GmbH, Bielefeld, Germany.
AmF/SnF2 group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pocket probing depths (PPDs) of ≥ 4 mm at a minimum of four teeth (except third molars)
  • age ≤ 18 to ≤ 75 years
  • at least 10 natural teeth in situ (except third molars)
  • non-smokers

You may not qualify if:

  • known systemic diseases that may influence the periodontal conditions
  • regular consumption of drugs that may interfere with periodontal conditions
  • undergoing or requiring extensive dental or orthodontic treatment
  • pregnancy or breastfeeding
  • professional periodontal therapy during 6 months prior to baseline.
  • periodontal pockets ≥ 6 mm in more than 2 sextants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Harks I, Jockel-Schneider Y, Schlagenhauf U, May TW, Gravemeier M, Prior K, Petersilka G, Ehmke B. 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. PLoS One. 2016 Jul 28;11(7):e0160142. doi: 10.1371/journal.pone.0160142. eCollection 2016.

    PMID: 27467683DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Meridolgamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Benjamin Ehmke, Prof. Dr.

    University of Münster, Department of Periodontology Waldeyerstr. 30, 48149 Münster

    PRINCIPAL INVESTIGATOR

  • Ulrich Schlagenhauf, Prof. Dr.

    University of Würzburg, Department of Periodontology Pleicherwall 2, 97070 Würzburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 3, 2016

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

March 3, 2016

Record last verified: 2016-02