Periodontal DiseasesPhase 2NCT00127244
Study Comparing Two Different Methods of Treating Periodontal Disease
A Phase 2 study testing Periodontal Treatment in people with Periodontal Diseases, run by The Forsyth Institute at 1 site in United States.
Trial summary
The purposes of this study are to: 1. compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and 2. determine the value of the two approaches to periodontal therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Periodontal Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Oct 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >/= 4 or more periodontally involved teeth as defined by pocket depth of >/= 6mm.
- >/= 14 teeth.
- > 18 years of age.
- Reside in the greater Boston area.
Who cannot join
- Those patients requiring prophylactic antibiotic for dental treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Traditional and Medical Models of Periodontal Therapy
The purposes of this study are to:
- compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
- determine the value of the two approaches to periodontal therapy.
Read the detailed description
This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis.
There are two significant reasons for testing a medical model of care. If the hypothesis is correct:
- this would increase access to periodontal care; and
- it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems.
These points argue for a direct comparison of the medical and traditional models of care.
- Conditions
- Periodontal Diseases
- Being tested
- Periodontal Treatment
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal TreatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment loss
Quality of life
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJun 2000
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Delta Dental Plan Massachusetts, Harvard University
- Investigators
- Richard Niederman, Principal investigator, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127244
- Sponsor's protocol ID
- NIDCR-13850
- Other IDs
- R01DE013850, DE-013850
- Status last verified
- Nov 2010
- First submitted
- 4 Aug 2005
- Last updated
- 2 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Traditional and Medical Models of Periodontal Therapy
- ClinicalTrials.gov ID
- NCT00127244
- Acronym / sponsor ID
- NIDCR-13850
- Conditions
- Periodontal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Delta Dental Plan Massachusetts, Harvard University
- Study start
- Jun 2000
- Study completion
- Oct 2004
- First posted
- 5 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to:
- compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
- determine the value of the two approaches to periodontal therapy.
Detailed description
This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis.
There are two significant reasons for testing a medical model of care. If the hypothesis is correct:
- this would increase access to periodontal care; and
- it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems.
These points argue for a direct comparison of the medical and traditional models of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >/= 4 or more periodontally involved teeth as defined by pocket depth of >/= 6mm.
- >/= 14 teeth.
- > 18 years of age.
- Reside in the greater Boston area.
Key exclusion criteria (1 listed)
- Those patients requiring prophylactic antibiotic for dental treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal Treatment | Procedure or surgery | – |
Primary outcome
Clinical attachment loss
Quality of life
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Niederman principal investigator
The Forsyth Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Periodontal Treatment in people with Periodontal Diseases, run by The Forsyth Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment loss. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2010.