Trial · NCT03374176
Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes
NCT03374176, Phase 3, Completed, Centro Universitario de Tonalá; results first posted 2020-06-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes. Trials, record NCT03374176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03374176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes
- NCT number
- NCT03374176
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Centro Universitario de Tonalá
- Conditions
- Periodontitis, Periodontal Pocket, Diabetes Mellitus
- Interventions
- Amoxicillin 500 mg / Metronidazole 250 mg, Clindamycin 300 mg
- First posted
- 2017-12-15
- Last updated
- 2020-09-16
- Results first posted
- 2020-06-23
- Limitations and caveats
The prin- cipal limitation of the present study was the absence of a group with SRP plus placebo. This study design, using a placebo group, could help us to evaluate the efficacy of clindamycin versus SRP alone.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Probing Depth | 7 days | The size of the periodontal pocket |
| Secondary | Sites With Plaques | 7 days | 0: no plaque 1. separate flecks of plaque at the cervical margin of the tooth 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth 3. a continuous band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. plaque covering two-thirds or more of the crown of the tooth. A higher scores mean a worse outcome |
| Secondary | Sites With Bleeding on Probing | 7 days | Refers to bleeding on probing 0: absence of inflammation 1. mild inflammation; a slight change in color, little change in the texture of any portion of but not the entire marginal or papillary gingival unit 2. mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit 3. moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4; severe inflammation; marked redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration |
| Secondary | Total Count of All Teeth Lost Across All Participants | 2 years | The total count of all teeth lost in all participants. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Probing Depth | 7 days | mm | MEAN | |
| SECONDARY | Sites With Plaques | 7 days | Sites | MEAN | |
| SECONDARY | Sites With Bleeding on Probing | 7 days | Sites | MEAN | |
| SECONDARY | Total Count of All Teeth Lost Across All Participants | 2 years | total count of all teeth lost | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Probing Depth | AMX-MET | 0.44 | Standard Deviation 0.27 | mm | |
| Probing Depth | Clindamycin | 0.50 | Standard Deviation 0.17 | mm | |
| Sites With Plaques | AMX-MET | 17.6 | Standard Deviation 13.3 | Sites | |
| Sites With Plaques | Clindamycin | 15.8 | Standard Deviation 10.0 | Sites | |
| Sites With Bleeding on Probing | AMX-MET | 16.1 | Standard Deviation 11.2 | Sites | |
| Sites With Bleeding on Probing | Clindamycin | 22.1 | Standard Deviation 12.9 | Sites | |
| Total Count of All Teeth Lost Across All Participants | AMX-MET | 0 | total count of all teeth lost | ||
| Total Count of All Teeth Lost Across All Participants | Clindamycin | 0 | total count of all teeth lost |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AMX-MET | 21 | |
| Overall Study | STARTED | Clindamycin | 21 | |
| Overall Study | COMPLETED | AMX-MET | 21 | |
| Overall Study | COMPLETED | Clindamycin | 21 | |
| Overall Study | NOT COMPLETED | AMX-MET | 0 | |
| Overall Study | NOT COMPLETED | Clindamycin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AMX-MET | 0 | 21 |
| Total, all-cause mortality | Clindamycin | 0 | 21 |
| Total, other adverse events | AMX-MET | 0 | 21 |
| Total, other adverse events | Clindamycin | 0 | 21 |
| Total, serious adverse events | AMX-MET | 0 | 21 |
| Total, serious adverse events | Clindamycin | 0 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AMX-MET vs Clindamycin: deaths from any cause | Trial comparisons |
| AMX-MET vs Clindamycin: serious adverse events | Trial comparisons |
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/NCT03374176
GET https://conductscience.org/api/trials/v1/NCT03374176/registered