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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change 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. | mm | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Clinical Attachment Level. | Scaling and Root Planing Only NonSmokers | Changes in mean CAL from baseline to 3 months | 0.11 | Standard Error 0.06 | mm |
| Change in Mean Clinical Attachment Level. | SRP Only Smokers | Changes in mean CAL from baseline to 3 months | 0.10 | Standard Error 0.04 | mm |
| Change in Mean Clinical Attachment Level. | SRP + Metronidazole NonSmokers | Changes in mean CAL from baseline to 3 months | 0.21 | Standard Error 0.05 | mm |
| Change in Mean Clinical Attachment Level. | SRP + Metronidazole Smokers | Changes in mean CAL from baseline to 3 months | 0.08 | Standard Error 0.06 | mm |
| Change in Mean Clinical Attachment Level. | SRP + MET + Amoxicillin + Doxycycline NonSmokers | Changes in mean CAL from baseline to 3 months | 0.29 | Standard Error 0.07 | mm |
| Change in Mean Clinical Attachment Level. | SRP + MET + Amoxicillin + Doxycycline Smokers | Changes in mean CAL from baseline to 3 months | 0.28 | Standard Error 0.06 | mm |
| Change in Mean Clinical Attachment Level. | Scaling and Root Planing Only NonSmokers | Changes in mean CAL from baseline to 6 months | 0.15 | Standard Error 0.06 | mm |
| Change in Mean Clinical Attachment Level. | SRP Only Smokers | Changes in mean CAL from baseline to 6 months | 0.19 | Standard Error 0.05 | mm |
| Change in Mean Clinical Attachment Level. | SRP + Metronidazole NonSmokers | Changes in mean CAL from baseline to 6 months | 0.19 | Standard Error 0.07 | mm |
| Change in Mean Clinical Attachment Level. | SRP + Metronidazole Smokers | Changes in mean CAL from baseline to 6 months | 0.13 | Standard Error 0.07 | mm |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Scaling and Root Planing (SRP) Only NonSmokers | 27 | |
| Overall Study | STARTED | SRP Only Smokers | 22 | |
| Overall Study | STARTED | SRP and Metronidazole (MET) NonSmokers | 30 | |
| Overall Study | STARTED | SRP and Metronidazole (MET) Smokers | 20 | |
| Overall Study | STARTED | SRP and Amoxicillin, MET, Local Tetracycline NonSmokers | 27 | |
| Overall Study | STARTED | SRP and Amoxicillin, MET, Local Tetracycline Smokers | 20 | |
| Overall Study | Baseline | Scaling and Root Planing (SRP) Only NonSmokers | 27 | |
| Overall Study | Baseline | SRP Only Smokers | 22 | |
| Overall Study | Baseline | SRP and Metronidazole (MET) NonSmokers | 30 | |
| Overall Study | Baseline | SRP and Metronidazole (MET) Smokers | 20 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal Upset | Gastrointestinal disorders | Scaling and Root Planing (SRP) Only NonSmokers | 8 | 27 | 8 |
| other | Gastrointestinal Upset | Gastrointestinal disorders | SRP Only Smokers | 4 | 22 | 4 |
| other | Gastrointestinal Upset | Gastrointestinal disorders | SRP and Metronidazole (MET) NonSmokers | 10 | 30 | 10 |
| other | Gastrointestinal Upset | Gastrointestinal disorders | SRP and Metronidazole (MET) Smokers | 3 | 20 | 3 |
| other | Gastrointestinal Upset | Gastrointestinal disorders | SRP and Amoxicillin, MET, Local Tetracycline NonSmokers | 6 | 27 | 6 |
| other | Gastrointestinal Upset | Gastrointestinal disorders | SRP and Amoxicillin, MET, Local Tetracycline Smokers | 5 | 20 | 5 |
| serious | hospitalizations | Surgical and medical procedures | Scaling and Root Planing (SRP) Only NonSmokers | 1 | 27 | 1 |
| serious | hospitalizations | Surgical and medical procedures | SRP Only Smokers | 0 | 22 | 0 |
| serious | hospitalizations | Surgical and medical procedures | SRP and Metronidazole (MET) NonSmokers | 2 | 30 | 2 |
| serious | hospitalizations | Surgical and medical procedures | SRP and Metronidazole (MET) Smokers | 2 | 20 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Scaling and Root Planing (SRP) Only NonSmokers | ||
| Total, all-cause mortality | SRP Only Smokers | ||
| Total, all-cause mortality | SRP and Metronidazole (MET) NonSmokers | ||
| Total, all-cause mortality | SRP and Metronidazole (MET) Smokers | ||
| Total, all-cause mortality | SRP and Amoxicillin, MET, Local Tetracycline NonSmokers | ||
| Total, all-cause mortality | SRP and Amoxicillin, MET, Local Tetracycline Smokers | ||
| Total, other adverse events | Scaling and Root Planing (SRP) Only NonSmokers | 8 | 27 |
| Total, other adverse events | SRP Only Smokers | 4 | 22 |
| Total, other adverse events | SRP and Metronidazole (MET) NonSmokers | 10 | 30 |
| Total, other adverse events | SRP and Metronidazole (MET) Smokers | 3 | 20 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33197289 | DERIVED |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DE014242 | Three Periodontal Therapies in Current & Non-Smokers | HAFFAJEE, ANNE DENISE | ADA FORSYTH INSTITUTE, INC. | NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH | 2003 to 2007 |
Source NIH RePORTER
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.
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