Biomarkers of Periodontal Disease Progression

NCT01489839 | Completed DMC

• 2 other identifiers: 10-174-E5U01DE021127-02
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 5

Brief Summary

The primary purpose of the study will be to look for biological biomarkers to determine which people with gum disease will have a worsening of the disease. A second objective of this study will be to look at the effects of periodontal treatment on the levels of the biomarkers that are identified.

Conditions

Periodontal Disease

Keywords

periodontal disease; biomarkers; periodontal treatment; clinical attachment level

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL)

  The primary study outcome will be progression of periodontal disease as determined by CAL. Initial disease progression at a site will be defined as loss of ≥2 mm in CAL at any assessment or follow-up visit compared with baseline. Subsequent disease progression will be similarly defined except that the loss in CAL will be compared with the last visit at which disease progression was detected.

  After the baseline visit, subjects will return to the clinic every 2 months (± 7 days relative to baseline) for 12 months.

Secondary Outcomes (1)

• Biomarker Levels compared between progressing and non-progressing sites as determined by CAL changes

  Levels measured every 2 months for 12 months

Study Arms (2)

Periodontal diseased

Subjects with periodontal disease will be enrolled. Subjects with mild disease will have at least 4 teeth with at least 1 site with pocketing of 5 mm or more and concomitant attachment greater than or equal to 2 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Subjects with severe disease will have at least 8 teeth with a site having \>5mm pocketing and loss of 3 mm attachment with evidence of alveolar bone loss in 2 teeth.

Other: Periodontal therapy

Periodontally healthy

Periodontally healthy subjects have no teeth with pocketing of 4 mm or greater and attachment loss, with the exception of the distal of the second molars where a pocket of 4 mm and concomitant attachment of up to 2 mm will be acceptable. Healthy subjects can have up to 3 sites with gingival recession and no radiographic evidence of alveolar bone loss.

Other: Periodontal therapy

Interventions

Periodontal therapy OTHER

All subjects will have professional dental prophylaxis and periodontal therapy withheld for 12 months during the disease progression and monitoring phase. After 12 months, subjects with periodontal disease will receive periodontal therapy to consist of scaling and root planing, and periodontally healthy subjects will receive professional dental prophylaxis. Subjects with periodontal disease will also receive Supportive Periodontal Therapy at the 3- and 6-month post-therapy visits. Subjects showing periodontal disease progression greater than a predetermined threshold during the monitoring or maintenance phases of the study will be given rescue therapy consisting of placement of a local antibiotic at the site of disease progression.

Periodontal diseased; Periodontally healthy

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 500 subjects (375 subjects with periodontal disease and 125 periodontally healthy subjects) will be enrolled at 4 centers in the US.

You may qualify if:

• To be eligible to participate in this study, a subject must meet all of the following criteria:
• Ability to understand, and willingness and ability to read and sign, the informed consent form.
• Age of at least 25 years.
• Ability to understand and follow directions for study procedures.
• Minimum of 20 natural teeth, excluding third molar teeth; at least 12 of these teeth must be pre-molars, first molars, or second molars.
• Willingness not to have professional dental prophylaxis or scaling for the duration of the disease progression and monitoring phase (12 months).
• Willingness to comply with all study procedures and be available for the duration of the study.
• For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner).
• Healthy periodontal subjects must have:
• Any tooth with 3 mm or less PD, irrespective of the attachment level, will be acceptable
• No teeth with PD of 4 mm or more and concomitant attachment loss, with the exception of the distal of the second molars where a PD of 4 mm and concomitant CAL of up to 2 mm will be acceptable.
• No radiographic evidence of alveolar bone loss (defined as a distance of greater than 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone); with the exception of the mandibular incisors where up to 3.0 mm of alveolar bone loss measured radiographically from the CEJ to the crest of the alveolar bone will be accepted.
• Mild periodontal disease subject: periodontal loss must meet the following criteria and must not meet the minimum criteria for severe periodontal loss:
• \. At least 4 teeth with at least 1 site of PD of 5 mm or more and concomitant CAL greater than or equal to 2 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Alveolar bone loss is defined as a distance of \> 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone.
• Subjects with severe periodontal loss must meet all of the following criteria:

You may not qualify if:

• Presence of orthodontic appliances.
• The following conditions noted on oral examination:
• Oral lichen planus
• Candidiasis
• Clinical leukoplakia
• Clinical erythroplakia
• Pemphigus
• Pemphigoid
• Other recurrent intraoral or perioral vesiculobullous diseases
• Aphthous ulcerations (major or minor). Subjects presenting with aphthous ulcers should be rescreened after 2 weeks. They will be eligible if the ulcers have healed and the subject does not have a history of frequent recurrences.
• Herpetic lesions. Subjects presenting with herpes labialis or intraoral herpes should be rescreened after 2 weeks. They will be eligible if the lesions have healed and the subject does not have a history of frequent recurrences.
• j. Traumatic ulcers. If a subject presents with a traumatic ulcer, he/she can be rescreened in 2-3 weeks. The subject will be eligible if the ulcers have healed.
• Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator.
• Root fragments, pericoronitis, endo-perio lesions, or other dental abscesses. Subjects may be rescreened after resolution of these dental conditions.
• Pregnancy or lactation.

Sponsors & Collaborators

• The Forsyth Institute: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• NYU Langone Health: collaborator
• State University of New York at Buffalo: collaborator
• University of Michigan: collaborator
• Southern Illinois University: collaborator

Study Sites (5)

Southern Illinois University

Edwardsville, Illinois, 62026, United States

Location

The Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14228, United States

Location

NYU College of Dentistry

New York, New York, 10010, United States

Location

Related Publications (1)

• Yost S, Duran-Pinedo AE, Teles R, Krishnan K, Frias-Lopez J. Functional signatures of oral dysbiosis during periodontitis progression revealed by microbial metatranscriptome analysis. Genome Med. 2015 Apr 27;7(1):27. doi: 10.1186/s13073-015-0153-3. eCollection 2015.

  PMID: 25918553 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The biological samples listed below will be obtained at baseline, each 2-month assessment visit for 12 months, and the 6-month post-therapy visit. Blood. Ten mL of blood will be obtained by venipuncture from the antecubital fossa. Subjects consenting to have a blood sample drawn for future DNA analysis will have an additional 7 mL of blood drawn at the baseline visit. Saliva. Each subject will provide a timed sample of whole saliva by expectorating into a sterile graduated cylinder. Gingival crevicular fluid. A GCF sample will be collected from the mesial and distal aspect of each posterior tooth (excluding third molars) using filter strips (Periopaper®) gently inserted 1 to 2 mm subgingivally. A total of up to 32 samples will be obtained. Subgingival plaque samples. Two plaque samples will be taken from the mesial and distal aspects of each posterior tooth (excluding third molars) for up to 64 samples.

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ricardo P Teles, DDS, DMSc

  The Forsyth Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 12, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: May 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2016-06

Locations

US (5)