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Trial · NCT00066066

Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

NCT00066066, Phase 2, Completed, The Forsyth Institute; results first posted 2013-04-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers. Trials, record NCT00066066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066066

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
NCT number
NCT00066066
Status
Completed
Phases
Phase 2
Enrollment
146 participants, actual
Lead sponsor
The Forsyth Institute
Conditions
Periodontitis, Periodontal Diseases
Interventions
Scaling and root planing, Metronidazole, Amoxicillin, Doxycycline
First posted
2003-08-05
Last updated
2013-04-22
Results first posted
2013-04-22

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Mean Clinical Attachment Level.Baseline, 3, 6 and 12 months
Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a "fixed" landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Mean Clinical Attachment Level.Baseline, 3, 6 and 12 months
Of the 146 subjects, 117 were included in the analysis, who had 2 or fewer missing monitoring visits. 84 subjects had complete data, 23 subjects had one missing visit and 10 subjects had 2 missing visits. For the 33 subjects with missing visits, data were carried forward. 68 subjects were non smokers and 49 subjects were current smokers.
mmMEAN

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Mean Clinical Attachment Level.Scaling and Root Planing Only NonSmokersChanges in mean CAL from baseline to 3 months0.11Standard Error 0.06mm
Change in Mean Clinical Attachment Level.SRP Only SmokersChanges in mean CAL from baseline to 3 months0.10Standard Error 0.04mm
Change in Mean Clinical Attachment Level.SRP + Metronidazole NonSmokersChanges in mean CAL from baseline to 3 months0.21Standard Error 0.05mm
Change in Mean Clinical Attachment Level.SRP + Metronidazole SmokersChanges in mean CAL from baseline to 3 months0.08Standard Error 0.06mm
Change in Mean Clinical Attachment Level.SRP + MET + Amoxicillin + Doxycycline NonSmokersChanges in mean CAL from baseline to 3 months0.29Standard Error 0.07mm
Change in Mean Clinical Attachment Level.SRP + MET + Amoxicillin + Doxycycline SmokersChanges in mean CAL from baseline to 3 months0.28Standard Error 0.06mm
Change in Mean Clinical Attachment Level.Scaling and Root Planing Only NonSmokersChanges in mean CAL from baseline to 6 months0.15Standard Error 0.06mm
Change in Mean Clinical Attachment Level.SRP Only SmokersChanges in mean CAL from baseline to 6 months0.19Standard Error 0.05mm
Change in Mean Clinical Attachment Level.SRP + Metronidazole NonSmokersChanges in mean CAL from baseline to 6 months0.19Standard Error 0.07mm
Change in Mean Clinical Attachment Level.SRP + Metronidazole SmokersChanges in mean CAL from baseline to 6 months0.13Standard Error 0.07mm

Participant flow42

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDScaling and Root Planing (SRP) Only NonSmokers27
Overall StudySTARTEDSRP Only Smokers22
Overall StudySTARTEDSRP and Metronidazole (MET) NonSmokers30
Overall StudySTARTEDSRP and Metronidazole (MET) Smokers20
Overall StudySTARTEDSRP and Amoxicillin, MET, Local Tetracycline NonSmokers27
Overall StudySTARTEDSRP and Amoxicillin, MET, Local Tetracycline Smokers20
Overall StudyBaselineScaling and Root Planing (SRP) Only NonSmokers27
Overall StudyBaselineSRP Only Smokers22
Overall StudyBaselineSRP and Metronidazole (MET) NonSmokers30
Overall StudyBaselineSRP and Metronidazole (MET) Smokers20

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherGastrointestinal UpsetGastrointestinal disordersScaling and Root Planing (SRP) Only NonSmokers8278
otherGastrointestinal UpsetGastrointestinal disordersSRP Only Smokers4224
otherGastrointestinal UpsetGastrointestinal disordersSRP and Metronidazole (MET) NonSmokers103010
otherGastrointestinal UpsetGastrointestinal disordersSRP and Metronidazole (MET) Smokers3203
otherGastrointestinal UpsetGastrointestinal disordersSRP and Amoxicillin, MET, Local Tetracycline NonSmokers6276
otherGastrointestinal UpsetGastrointestinal disordersSRP and Amoxicillin, MET, Local Tetracycline Smokers5205
serioushospitalizationsSurgical and medical proceduresScaling and Root Planing (SRP) Only NonSmokers1271
serioushospitalizationsSurgical and medical proceduresSRP Only Smokers0220
serioushospitalizationsSurgical and medical proceduresSRP and Metronidazole (MET) NonSmokers2302
serioushospitalizationsSurgical and medical proceduresSRP and Metronidazole (MET) Smokers2202

Adverse event totals18

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityScaling and Root Planing (SRP) Only NonSmokers
Total, all-cause mortalitySRP Only Smokers
Total, all-cause mortalitySRP and Metronidazole (MET) NonSmokers
Total, all-cause mortalitySRP and Metronidazole (MET) Smokers
Total, all-cause mortalitySRP and Amoxicillin, MET, Local Tetracycline NonSmokers
Total, all-cause mortalitySRP and Amoxicillin, MET, Local Tetracycline Smokers
Total, other adverse eventsScaling and Root Planing (SRP) Only NonSmokers827
Total, other adverse eventsSRP Only Smokers422
Total, other adverse eventsSRP and Metronidazole (MET) NonSmokers1030
Total, other adverse eventsSRP and Metronidazole (MET) Smokers320

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
33197289DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01DE014242Three Periodontal Therapies in Current & Non-SmokersHAFFAJEE, ANNE DENISEADA FORSYTH INSTITUTE, INC.NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH2003 to 2007

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00066066

GET https://conductscience.org/api/trials/v1/NCT00066066/flow?page=2