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Dietary Supplements and Periodontal Wound Healing

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ClinicalTrials.gov Identifier: NCT02315222
Recruitment Status : Unknown
Verified December 2014 by Giulio Rasperini, University of Milan.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Giulio Rasperini, University of Milan

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

Condition or disease Intervention/treatment Phase
Periodontitis Dietary Supplement: Regenium Dietary Supplement: Placebo Procedure: Full Mouth Disinfection Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Dietary Supplements on Oral and Periodontal Wound Healing
Study Start Date : November 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Test
Dietary Supplementation
Dietary Supplement: Regenium
Procedure: Full Mouth Disinfection
Placebo Comparator: Control
Placebo Supplementation
Dietary Supplement: Placebo
Procedure: Full Mouth Disinfection



Primary Outcome Measures :
  1. Clinical Attachment Level (CAL) [ Time Frame: 3 months ]
  2. Periodontal Pocket Depth (PPD) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Tooth mobility [ Time Frame: 3 months ]
  2. Full Mouth Bleeding Score (FMBS) [ Time Frame: 3 months ]
  3. Full Mouth Plaque Score (FMPS) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315222


Contacts
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Contact: Giulio Rasperini 335 8130194 giulio.rasperini@unimi.it
Contact: Giorgio Pagni +39 335 6861544 giorgio.pagni@gmail.com

Locations
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Italy
Ospedale Militare Recruiting
Milano, MI, Italy, 20147
Contact: Cesare Mauro, Doctor/Capitan    +390240088381    zar77c@libero.it   
Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico Recruiting
Milan, MI, Italy, 20122
Contact: Giulio Rasperini, Professor    +393358130194    giulio.rasperini@unimi.it   
Studio Odontoiatrico Professor Rasperini Recruiting
Piacenza, PC, Italy, 29121
Contact: Giulio Rasperini, Professor    +393358130194    giulio@studiorasperini.it   
Sponsors and Collaborators
University of Milan

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Responsible Party: Giulio Rasperini, Professor, University of Milan
ClinicalTrials.gov Identifier: NCT02315222     History of Changes
Other Study ID Numbers: Regenium
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Giulio Rasperini, University of Milan:
Nutriomics
Dietary supplements
Scaling and root planing
full mouth disinfection

Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases