Hexetidine and Chlorobutanol for Lesions Due to Prostheses

Phase 4

Completed

• Conditions: Oral Mucositis
• Interventions: Drug: chlorobutanol, hexetidine; Drug: Chlorhexidine

• Registration Number: NCT01115049
• Lead Sponsor: Federico II University

Brief Summary

Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses.

Methods: The present prospective randomized clinical trial was performed on 44 patients. The experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and clinical examinations. The results were statistically analyzed. The following variables were recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of pain after rinsing.

Detailed Description

The aim of the present prospective, randomized, triple-blind controlled clinical trial was to evaluate the efficacy of an innovative mouthwash (emulsion) in the treatment of lesions of oral mucosae due to removable prostheses. The tested preparation contained two active molecules: a topical antiseptic (0.1% hexetidine) and a local anesthetic (0.5% chlorobutanol).

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-04
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-30
• Last Update Submitted: 2010-04-30
• Study First Posted: 2010-05-03
• Last Update Posted: 2010-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Use of removable partial or complete dentures;
• Presence of lesions of oral mucosae due to dentures;
• Absence of any concomitant local or systemic pathology;
• Absence of pregnancy or breastfeeding;
• Negative allergic anamnesis;
• Negative anamnesis for recurrent aphthous stomatitis;
• No taking medicines with potential pharmacologic interactions with molecules to be tested;
• No taking antibiotics and/or painkillers for at least 6 months before entering the experimentation;
• Good oral hygiene with a full-mouth plaque score ≤25%;
• Non smoking or light smoking (≤10 cigarettes/day) status.

Exclusion Criteria

Missing one or more of the above described conditions automatically excluded a subject from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental mouthwash	chlorobutanol, hexetidine	The experimental mouthwash (Buccagel®, Curaden Healthcare, Saronno, Italy) was made up of: purified water, dicaprylyl-ether, coco-caprylate caprate, xylitol, glyceryl-stearate, ceteareth-20, ceteareth-12, cetyl-palmitate, cetearyl-alcohol, chlorobutanol, aroma, hexetidine, methylparaben, propylparaben, sodium saccharin, citric acid and colorant C.I. 16255.
Chlorexidine-based mouthwash	Chlorhexidine	A conventional commercial mouthwash (Curasept® ADS 0.20%, Curaden Healthcare, Saronno, Italy) made up of: water, xylitol, propylenglycol, Peg-40 of hydrogenated ricin oil, ascorbic acid, chlorhexidine digluconate, aroma, poloxamer 407, sodium metabisulfite, sodium citrate and colorant C.I. 42090.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of tolerability	Weekly	Presence of mucosal lesions due to incongruous removable prostheses.

Secondary Outcome Measures

Name	Time	Method
Pain scores on the visual analogue scale	Weekly	Lasting of painful symptomatology after rinsing.

Trial Locations

Locations (1)

University "Federico II", Department of Prosthodontics; 🇮🇹 Naples, Italy