Tisuacryl® in Dental Hyperesthesia

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Tisuacryl® in Dental Hyperesthesia. Clinical Trial Phase III

Secondary indentifying numbers:

EC4

Issuing authority of the secondary identifying numbers:

Center of Biomaterials. BIOMAT

Source(s) of monetary or material support:

Center of Biomaterials of Havana University, Clínica Estomatologica of Bauta

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center of State Control of the medical equipment(CCEEM)

Authorization date :

13/08/2007

Reference number:

N/A

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Mayra

Midle name:

de la Caridad

Last name:

Perez Alvarez

Medical Specialty :

Specialist in General Integral Stomatology

Affiliation:

Bauta Teaching Stomatological Clinic

Postal address:

Avenida 251 No. 13202

City:

Artemisa

Country:

Cuba

Zip Code:

32 400

Telephone:

+53-047372623

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Clinic XI Festival, Dra. M. Iraida Fernández Díaz

Havana, Clinic of San Antonio de los Baños, Dra. Luvenia García Rodríguz.

Havana, Clinic Guanajay, Dr. Eladio Traviesas.

Havana, Clinic Artemisa, Dr. Ricardo Rodríguez Llanes

Matanzas, Clinic Varadero, Dra. María del Carmen Rodríguez Moreno

Matanzas, Clinic Sede III Congreso del PCC, Dra. Olga Febles Lebrigios,

Pinar del Río, Hospital Briones Montoto, Dra. María del Carmen Ginebra

Research ethics committees:

Approved by Ethics Committee especially organized for the study, 5 de Julio 2007

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

10/09/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Dental Hyperesthesia

Health condition(s) code:

Hyperesthesia

Dentin Sensitivity

Tooth Diseases

Stomatognathic Diseases

Somatosensory Disorders

Sensation Disorders

Neurologic Manifestations

Intervention(s):

Patients with dental hyperesthesia as evidenced by clinical history, underwent one minute, antiseptic mouth rinsing with clorhexidine 0,2%, the operative mouth field is set, the tooth surface is dried with the dental equipment for 15 seconds, alcohol 90º GL is applied, and a drop of the tissue adhesive Tisuacryl® is applied on the retracted area and left to dry for 60 seconds. If symptoms have not subsided, treatment with the same technique is repeated on 48th, 96th and on the fifth day.

Intervention code:

Chlorhexidine

Tissue Adhesives

Mouthwashes

Intervention keyword:

Tisuacryl

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Pain relief, 48 hours, 96 hours, 5 days, 6 days No adverse reactions, up to 6 days

Key secondary outcomes:

Irritation of oral mucosa around the site after the application of the product, 48 hours, 96 hours, 5 days, 6 days. Warmth on treated area, 48 hours, 96 hours, 5 days, 6 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

75 years

Inclusion criteria:

Patients older than 20 years old and younger than 75 years old with dental hyperesthesia who consented to participate in the clinical trial

Exclusion criteria:

Patients with malignant neoplasia in areas close to the site of treatment. Patients with mental incapacity and/or severe psychological disorders Pregnant or breastfeeding women Patients with allergic reactions to gentian violet or acrylics Patients with uncontrolled diabetes Patients with alcoholism or other drugs addictions Patients that do not consent to participate in the study

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Placebo

Study design:

Single group

Phase:

3

Target sample size:

160

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Rosa

Middle Name:

Mayelin

Last Name:

Guerra Bretaña

Specialty:

Doctor of Chemical Sciences

Affiliation:

Center of Biomaterials of Havana University

Postal Address:

Centro de Biomateriales, Ave. Universidad e/Ronda y G, Vedado.

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

(537)- 8735477

Email :

mayelin@biomat.uh.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayra

Middle Name:

de la Caridad

Last Name:

Perez Alvarez

Specialty:

Specialist in General Integral Stomatology

Affiliation:

Stomatological Educational Clinic, Bauta

Postal Address:

Ave 251 No. 13201 e/ 132 y 134, Bauta.

City:

La Habana

Country:

Cuba

Zip Code:

32400

Telephone:

(53)-047-374197

Email :

dntimefa@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000064

Date of Registration in Primary Registry:

2008-09-18

Record Verification Date:

2008-09-03 20:00

Link to the spanish version:

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Tisuacryl® in Dental Hyperesthesia

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