Efficacy of Oral Hygiene Regimens in Patients Undergoing Non-Surgical Periodontal Treatment
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-70
SponsorColgate Palmolive
About this trial
The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females, between 30-70 years of age, inclusive.
Good general health. Minimum of 15 uncrowned permanent natural teeth (excluding third molars and crowns).
Clinical diagnosis of stage II generalized periodontitis.
Disqualifiers
Periodontal treatment undergone 3 months before the beginning of the study. - Mucosal oral pathology.
Uncontrolled systemic chronic disease that may interfere with host response. - Use of anti-inflammatory and antibiotic within 3 months prior to the start of the study, scheduled to start such intake during the treatment phase, or use of therapeutic mouthwash within the last three months.
Need for antibiotic prophylaxis.
Participation in any other clinical study.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Oral Hygiene Regimen
Combination productParticipants use a 0.12% chlorhexidine mouthwash and stannous fluoride toothpaste for 3 weeks (Regimen I). Afterwards, they switch to a 0.09% CPC and 0.28% Zinc Lactate mouthwash with fluoride and stannous fluoride toothpaste (Regimen II). Both regimens include a soft bristle toothbrush and dental floss.
Placebo Oral Hygiene Regimen
Combination productParticipants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Test GroupExperimental treatment 1 intervention
Group B: Negative Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pocket depth (PD) reduction
The distance measured between the gingival margin and the bottom of the gingival sulcus or the periodontal pocket, assessed at six sites per tooth using a calibrated periodontal probe.
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months post-treatmentSecondary outcomes
1
Change in Gingival Index (GI)
Evaluated using the Löe-Silness Gingival Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing gingival inflammation and bleeding.
Time frame
Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment2
Change in Plaque Index (PI)
Evaluated using the Löe \& Silness Plaque Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing microbial plaque accumulation.
Time frame
Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment3
Clinical Attachment Level (CAL) gain
The distance measured between the cemento-enamel junction and the bottom of the gingival sulcus or periodontal pocket, assessed at six sites per tooth.
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment4
Change in Bleeding on Probing (BOP)
Evaluated using the Ainamo \& Bay Index, scoring the presence or absence of bleeding in the gingival sulcus after gentle probing, expressed as a percentage of bleeding sites over total sites.
Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: