Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tooth Loss in Periodontitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02091258
Recruitment Status : Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
Tooth loss in periodontitis patients is associated with patient and site factors as well as with treatment provided. Not much is known about long-term tooth loss in periodontitis patients in private practice in the UK. The study plans to follow-up 200 subjects with periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment provided, site and patient risk factors on tooth loss will be studied.

Condition or disease
Periodontitis

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tooth Loss in Periodontitis Patients on Long-term Maintenance in Private Practice
Study Start Date : June 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Tooth loss [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
200 patients with periodontitis on maintenance therapy (after initial/ corrective periodontal therapy) will be included in the study
Criteria

INCLUSION CRITERIA:

  1. Initial diagnosis of chronic or aggressive periodontitis (Lindhe et al. 1999, Lang et al. 1999), with at least two sites with PPD and CAL ≥5mm
  2. Diagnosed and treated by the same periodontist (LN)
  3. Willing to give written informed consent for study participation
  4. Willing to undergo SPT as per standard of care for at least 5 years

EXCLUSION CRITERIA:

  1. Serious medical history that prevents patients from undergoing dental treatment
  2. History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  3. Current alcohol or drug abuse
  4. Self-reported pregnancy or lactation
  5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may compromise trial participation and/or interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial

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): NCT02091258


Locations
Layout table for location information
United Kingdom
The Dentist
Bishop's Stortford, Herts, United Kingdom, CM23 3AZ
Ravenscourt Dental Practice
London, United Kingdom, W60SL
Sponsors and Collaborators
University College, London
Investigators
Layout table for investigator information
Principal Investigator: Luigi Nibali, PhD UCL

Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02091258     History of Changes
Other Study ID Numbers: UCL 14/0110
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases