NCT02315222

Brief Summary

Patient with periodontal disease undergoing full mouth disinfection will be given dietary supplements or placebo and reevaluated after 3 months.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

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

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 9, 2014

Last Update Submit

December 10, 2014

Conditions

Periodontitis

Keywords

NutriomicsDietary supplementsScaling and root planingfull mouth disinfection

Outcome Measures

Primary Outcomes (2)

  • Clinical Attachment Level (CAL)

    3 months

  • Periodontal Pocket Depth (PPD)

    3 months

Secondary Outcomes (3)

  • Tooth mobility

    3 months

  • Full Mouth Bleeding Score (FMBS)

    3 months

  • Full Mouth Plaque Score (FMPS)

    3 months

Study Arms (2)

Test

ACTIVE COMPARATOR

Dietary Supplementation

Dietary Supplement: RegeniumProcedure: Full Mouth Disinfection

Control

PLACEBO COMPARATOR

Placebo Supplementation

Dietary Supplement: PlaceboProcedure: Full Mouth Disinfection

Interventions

RegeniumDIETARY_SUPPLEMENT
Test
PlaceboDIETARY_SUPPLEMENT
Control
Full Mouth DisinfectionPROCEDURE
ControlTest

Eligibility Criteria

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

You may qualify if:

  • severe periodontal disease: at least 2 sites with Probing Pocket Depth (PPD)\>7mm, Bleeding On Probing (BOP)\> 25%
  • Age between 18 and 65 years
  • Signed informed consent

You may not qualify if:

  • Systemic diseases that may affect periodontal status
  • Metabolic disorders
  • Nutritional conditions that may alter the formation and maturation of connective tissue
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

RECRUITING

Ospedale Militare

Milan, MI, 20147, Italy

RECRUITING

Studio Odontoiatrico Professor Rasperini

Piacenza, PC, 29121, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Giulio Rasperini

CONTACT

335 8130194giulio.rasperini@unimi.it

Giorgio Pagni

CONTACT

+39 335 6861544giorgio.pagni@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 11, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations

IT(3)