NCT02091258

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

March 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2015

Enrollment Period

5.9 years

First QC Date

March 17, 2014

Last Update Submit

September 26, 2017

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Tooth loss

    5 years

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 patients with periodontitis on maintenance therapy (after initial/ corrective periodontal therapy) will be included in the study

You may qualify if:

  • 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
  • Diagnosed and treated by the same periodontist (LN)
  • Willing to give written informed consent for study participation
  • Willing to undergo SPT as per standard of care for at least 5 years

You may not qualify if:

  • Serious medical history that prevents patients from undergoing dental treatment
  • History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  • Current alcohol or drug abuse
  • Self-reported pregnancy or lactation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Dentist

Bishop's Stortford, Herts, CM23 3AZ, United Kingdom

Location

Ravenscourt Dental Practice

London, W60SL, United Kingdom

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Luigi Nibali, PhD

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 19, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

September 27, 2017

Record last verified: 2015-09

Locations

GB(2)