Hexetidine and Chlorobutanol for Lesions Due to Prostheses

NCT01115049 | Completed Phase 4 DMC

• 1 other identifier: FEDII_RS_1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of tolerability

  Presence of mucosal lesions due to incongruous removable prostheses.

  Weekly

Secondary Outcomes (1)

• Pain scores on the visual analogue scale

  Weekly

Study Arms (2)

Experimental mouthwash

EXPERIMENTAL

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.

Drug: chlorobutanol, hexetidine

Chlorexidine-based mouthwash

ACTIVE COMPARATOR

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.

Drug: Chlorhexidine

Interventions

chlorobutanol, hexetidine DRUG

3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash

Also known as: Curasept® ADS 0.20%, Curaden Healthcare

Experimental mouthwash

Chlorhexidine DRUG

3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash

Also known as: Curasept® ADS 0.20%, Curaden Healthcare

Chlorexidine-based mouthwash

Eligibility Criteria

• Age: 37 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University "Federico II", Department of Prosthodontics

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Chlorobutanol; Hexetidine; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorohydrins; Alcohols; Organic Chemicals; Butanols; Fatty Alcohols; Lipids; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Fernando Zarone, MD, DDS

  University "Federco II" of Naples, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: May 3, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 3, 2010

Record last verified: 2010-04

Locations

IT (1)