PeriodontitisPhase 3NCT01098448
Control of Periodontal Infections
A Phase 3 study testing scaling and root planing, local tetracycline and systemic metronidazole and amoxicillin in people with Periodontitis, run by The Forsyth Institute at 1 site in United States.
Trial summary
The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- scaling and root planing, local tetracycline and systemic metronidazole and amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Dec 2004
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- greater than 20 years of age
- had a least 15 natural teeth
- in good general health
- at least 4 teeth with pockets > 6 mm
- at least 8 teeth with AL > 3 mm at baseline
Who cannot join
- pregnant or nursing (if female)
- having antibiotic or periodontal therapy in the previous three months
- systemic conditions that would affect the course of periodontal disease
- systemic conditions that required antibiotic coverage
- allergic to drugs used in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis.
Read the detailed description
In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.
- Conditions
- Periodontitis
- Being tested
- scaling and root planing, local tetracycline, systemic metronidazole and amoxicillin, surgery, local antibiotics and systemic metronidazole and amoxicillin
- Keywords
- Amoxicillin, antibiotics, chronic periodontitis, local drug delivery, metronidazol, randomized controlled trial, subgingival scaling, surgery, tetracycline, moderate to advanced chronic periodontitis
- Medical subject headings
- Periodontitis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingOther
scaling and root planing as a single therapy
local tetracyclineDrug
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
systemic metronidazole and amoxicillinDrug
systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
surgeryOther
periodontal surgery in residual pockets of >4mm
local antibiotics and systemic metronidazole and amoxicillinDrug
1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
local tetracycline and periodontal surgeryOther
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
periodontal surgery and systemic metronidazole and amoxicillinOther
surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
surgery, local tetracycline, systemic metronidazole and amoxicillinOther
periodontal surgery in residual pockets >4mm, tetracycline ibers releasing approximately 1.7 mg/tooth in pockets >5mm, systemic metronidazlo (250mg tidx14d) and amoxicillin (500 mg bidx14d)
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planing | Active comparator | scaling and root planing as a solo therapy Receives: Other: scaling and root planing |
| Periodontal surgery | Experimental | Not described Receives: Other: surgery |
| systemic antibiotics | Experimental | Not described Receives: Drug: systemic metronidazole and amoxicillin |
| Local delivery of tetracycline | Experimental | Not described Receives: Drug: local tetracycline |
| local antibiotic and systemic antibiotics | Experimental | Not described Receives: Drug: local antibiotics and systemic metronidazole and amoxicillin |
| local antibiotics and surgery | Experimental | Not described Receives: Other: local tetracycline and periodontal surgery |
| systemic antibiotics and surgery | Experimental | Not described Receives: Other: periodontal surgery and systemic metronidazole and amoxicillin |
| local and systemic antibiotics and surgery | Experimental | Not described Receives: Other: surgery, local tetracycline, systemic metronidazole and amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level Gain
Measured: 24 months
Secondary outcomes (1)
Probing pocket depth reduction
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startSep 1999
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Boston University
- Investigators
- J Max Goodson, DDS, PhD, Principal investigator, The Forsyth InstituteAnne D Haffajee, BDS, Principal investigator, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098448
- Sponsor's protocol ID
- NIDCR-012861
- Status last verified
- Apr 2010
- First submitted
- 1 Apr 2010
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Periodontal Infections
- ClinicalTrials.gov ID
- NCT01098448
- Acronym / sponsor ID
- NIDCR-012861
- Conditions
- Periodontitis
- Keywords
- Amoxicillin, antibiotics, chronic periodontitis, local drug delivery, metronidazol, randomized controlled trial, subgingival scaling, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Collaborators
- Göteborg University, Boston University
- Study start
- Sep 1999
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 2 Apr 2010 (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 purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis.
Detailed description
In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing | Active comparator | Other: scaling and root planingscaling and root planing as a solo therapy |
| Periodontal surgery | Experimental | Other: surgery |
| systemic antibiotics | Experimental | Drug: systemic metronidazole and amoxicillin |
| Local delivery of tetracycline | Experimental | Drug: local tetracycline |
| local antibiotic and systemic antibiotics | Experimental | Drug: local antibiotics and systemic metronidazole and amoxicillin |
| local antibiotics and surgery | Experimental | Other: local tetracycline and periodontal surgery |
| systemic antibiotics and surgery | Experimental | Other: periodontal surgery and systemic metronidazole and amoxicillin |
| local and systemic antibiotics and surgery | Experimental | Other: surgery, local tetracycline, systemic metronidazole and amoxicillin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- greater than 20 years of age
- had a least 15 natural teeth
- in good general health
- at least 4 teeth with pockets > 6 mm
- at least 8 teeth with AL > 3 mm at baseline
Key exclusion criteria (5 listed)
- pregnant or nursing (if female)
- having antibiotic or periodontal therapy in the previous three months
- systemic conditions that would affect the course of periodontal disease
- systemic conditions that required antibiotic coverage
- allergic to drugs used in the study
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 |
|---|---|---|
| scaling and root planingscaling and root planing as a single therapy | Other | Scaling and root planing |
| local tetracyclinelocal delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm | Drug | Local delivery of tetracycline |
| systemic metronidazole and amoxicillinsystemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14 | Drug | systemic antibiotics |
| surgeryperiodontal surgery in residual pockets of >4mm | Other | Periodontal surgery |
| local antibiotics and systemic metronidazole and amoxicillin1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d) | Drug | local antibiotic and systemic antibiotics |
| local tetracycline and periodontal surgerylocal delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm | Other | local antibiotics and surgery |
| periodontal surgery and systemic metronidazole and amoxicillinsurgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d) | Other | systemic antibiotics and surgery |
| surgery, local tetracycline, systemic metronidazole and amoxicillinperiodontal surgery in residual pockets >4mm, tetracycline ibers releasing approximately 1.7 mg/tooth in pockets >5mm, systemic metronidazlo (250mg tidx14d) and amoxicillin (500 mg bidx14d) | Other | local and systemic antibiotics and surgery |
Primary outcome
Clinical Attachment Level Gain
Time frame: 24 months
1 secondary outcome
Probing pocket depth reduction
Time frame: 24 months
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 Apr 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.
J Max Goodson, DDS, PhD principal investigator
The Forsyth Institute
Anne D Haffajee, BDS 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 3 study testing scaling and root planing, local tetracycline and systemic metronidazole and amoxicillin in people with Periodontitis, 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 5 inclusion and 5 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 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Level Gain (time frame: 24 months). 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 Apr 2010.