About this trial

The focus of this study is on two types of mouthwashes - one containing a chlorhexidine (CHX) at 0.2% (CHX), and the other one containing CHX at a lower concentration of 0.12% with cetylpyridinium chloride (CPC). Both mouthwashes are used to help in the treatment of gum disease. CHX has been known for a long time for its effectiveness against plaque and mouth inflammation. It could inhibit and even kill them. However higher concentrations of CHX comes with unwanted side effect including altered taste, teeth staining and irritation in the mouth. Interestingly, these side effects seem to occur less frequently when a lower concentration CHX solution is used. CPC also combats bacteria by adhering quickly to the surfaces inside your mouth, although it has less substantivity than CHX, it has been shown to reduce plaque and gum inflammation effectively, and it typically causes fewer side effects than CHX. We hypothesize that this new formulation of CHX 0.12%+CPC mouthwash is non-inferior to CHX 0.2% in terms of its anti-plaque and anti-inflammatory properties while presenting with less side effects after 21 days of use. Microbiological samples and fluids from periodontal pockets will be collected before and after treatment for analysis of microbiological effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consenting patients with at least 6 evaluable teeth in each quadrant, including minimum 1 molar and 1 premolar.

Generalized stage II-III periodontitis patients.

Baseline BOP > 25%.

No known allergy or adverse effects to CHX or CPC

Disqualifiers

Unable to provide written consent.

Non-compliant study procedures.

Patients with medical (including psychiatric) and pharmacotherapeutic histories that, in the investigator's opinion, may compromise the protocol.

Patients requiring antibiotics prophylaxis for dental procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

Experimental (chlorhexidine)
Other intervention
Test group: administration of experimental antiseptic (CHX 0.12%+CPC 0.05%) for 3 weeks
Control (chlorhexidine with cetylpyridinium chloride)
Other intervention
Active comparator: administration of control antiseptic (CHX 0.2%) for 3 weeks

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Active controlActive comparator 1 intervention

Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

% Bleeding on probing (BoP)

% BoP will be assessed at 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) in a dichotomous manner (Mühlemann \& Son, 1971). Bleeding will be positive after 15 seconds of probing the gingival sulcus to the most apical stop. The percentage of the full mouth BoP will be reported.

Time frame

2 months

Secondary outcomes

1

% Bleeding on probing (BoP)

% BoP will be assessed at 6 surfaces (mesiobuccal, mid buccal, disto-buccal, mesio-oral, mid-oral, disto-oral.) in a dichotomous manner (Mühlemann \& Son, 1971). Bleeding will be positive after 15 seconds of probing the gingival sulcus to the most apical stop. The percentage of the full mouth BoP will be reported.

Time frame

21 days

2

Macpherson modification of the Lobene Stain Index (MLSI)

Tooth staining assessment by the Macpherson modification of the Lobene Stain Index (MLSI) (L. M. Macpherson, K. W. Stephen, A. Joiner, F. Schäfer, \& E. Huntington, 2000) on index tooth (11, 12, 21, 22, 31, 32, 41, 42). If an incisor is missing, the nearest canine will serve as substitute where appropriate.

Time frame

21 days and 2 months

3

Full mouth plaque score

Full Mouth Plaque Score (FMPS) (O'Leary et al., 1972) will be measured as an indicator of oral hygiene on the mesial, distal, buccal and oral surfaces of each tooth. The FMPS will be assessed with the following formula: Number of surfaces with plaque/Total number of surfaces x 100%

Time frame

21 days and 2 months

4

Clinical attachment level

CAL measures the distance from the cemento-enamel junction of the tooth to the base of the periodontal pocket. CAL will be measured at baseline and 2 months by recording the distance from the cervical line to the bottom of the probable pocket at 6 sites (Mesio-buccal, mid-buccal, disto-buccal, mesio-oral, mid-oral and disto-oral) for each of the study teeth.

Time frame

2 months

Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts