Dental Cement in Post-operative Sensitivity: Randomized Clinical Trial

NCT04870294 | Completed DMC

• 1 other identifier: Clinical study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Context: CEMENT PBS CIMMO DTA® has physical and biological properties that classify it as a biocompatible material and inducer of biomineralization, attributes that qualify it as material as an indirect pulp capper in permanent tooth restorations. Objective: The present clinical study proposes the use of PBS CIMMO DTA® cement as an indirect pulp capper, in resin restorations composed of permanent molars and premolars. The objective was to minimize postoperative sensitivity arising from restorative procedures. Method: Randomized clinical trial with two arms, double blind, interventional, prospective. The sample consisted of 20 male patients, with an average age of 20 years. Totaling 70 teeth to be treated. The teeth were divided into two groups: Group R (Control Group, n = 35), treated with a standard restorative procedure. Group D (Study group n = 35), treated using CEMENT PBS CIMMO DTA®, as an indirect capper of the pulp wall. The evaluation was carried out by a masked examiner for both groups. Sensitivity tests were performed before the restorative procedure, at 48 hours, 7, 15 and 30 days after the procedure. The analysis included pain caused by thermal stimuli: Cold Test (TM); horizontal (TPH) and vertical (TPV) percussion; Bite Test (TM) and Pain Decline Time (DD) was measured. Measured using Visual Analog Scale (EVA).

Conditions

Restored Decayed Teeth and Post-operative Sensitivity

Keywords

Dentistry, Operative; Dental Restoration, Permanent; Dental Caries; Dental Pulp Capping; Dental Materials

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative sensitivity in posterior teeth: before the procedure, 48 hours later, 7; 15 and 30 days later. Thermal test.

  Evaluate the postoperative sensitivity (thermal test) on posterior teeth, restored with CEMENT PBS CIMMO DTA®, as a lining material, and later restorations with composite resin.

  Sensitivity tests (thermal tests) were performed before the restorative procedure, 48 hours, 7, 15 and 30 days after the procedures

Secondary Outcomes (1)

• Evaluation of postoperative sensitivity in posterior teeth. Sensitivity test. Before the procedure, 48 hours later, 7; 15 and 30 days later. Percussion test.

  Sensitivity tests (percussion tests) were performed before the restorative procedure, 48 hours, 7, 15 and 30 days after the procedures

Other Outcomes (1)

• Evaluation of postoperative sensitivity in posterior teeth. Sensitivity test. Before the procedure, 48 hours later, 7; 15 and 30 days later. Masticatory strength test.

  Sensitivity tests (masticatory strength tests) were performed before the restorative procedure, 48 hours, 7, 15 and 30 days after the procedures.

Study Arms (2)

Teeth treated with composite resin, control group

ACTIVE COMPARATOR

The teeth grouped in group R were treated with composite resin restoration without liner material, considered a control group.

Device: Teeth treated with composite resin, control group

Teeth treated with lining, pulp wall with PBS DTA® cement and composite resin restoration

EXPERIMENTAL

The teeth grouped in group D received PBS CIMMO DTA® as indirect capping material of the cavity, followed by restoration of composite resin.

Device: Teeth treated with lining, pulp wall with PBS DTA® cement and composite resin restoration

Interventions

Teeth treated with composite resin, control group DEVICE

The teeth grouped in group R were treated with composite resin restoration without liner material.

Also known as: Filtek Z350 XT® composite resin (3M ESPE Dental Products TM, St. Paul, MN, USA)

Teeth treated with composite resin, control group

Teeth treated with lining, pulp wall with PBS DTA® cement and composite resin restoration DEVICE

The teeth grouped in group D received PBS CIMMO DTA® as indirect capping material of the cavity, followed by restoration of composite resin.

Also known as: PBS CIMMO DTA® cement.

Teeth treated with lining, pulp wall with PBS DTA® cement and composite resin restoration

Eligibility Criteria

• Age: 18 Years - 20 Years
• Gender Eligibility Details: Patients from the Dental Office of the 14th GAC - Pouso Alegre (MG), Military Organization of the Brazilian Army. Therefore, all are male, as they belong to the military organization for men only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Minimum age of 18 years, with maximum age of 20 years.
• Periapical radiography for diagnosis with detection of the presence of carious lesion in premolar or permanent molar dentin.
• Lesion depth and cervical width of at least 1 mm, without pulp exposure.
• Presence of the antagonist, which must be a natural tooth, the same for adjacent teeth.
• Presence of vital pulp and absence of spontaneous painful symptoms.
• Presence of teeth without prior restorative treatment and oral health.

You may not qualify if:

• Patients who did not show up for post-operative evaluations.
• Patients who gave up participating in the study, after being included, for personal reasons.
• Patients tested positive for the SARS-Cov-2 virus, unable to be assessed for the required confinement.
• Treated patients in which the teeth presented, in the postoperative evaluations, the presence of inflammation and necrosis.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Univás

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• José Dias Silva Neto

  Universidade do Vale do Sapucaí

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study has double blind masking: as for patients and professional evaluator of the results
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Comparison of two types of intervention: composite resin restoration and cavity lining before composite resin restoration.

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: May 3, 2021
• Study Start: March 18, 2020
• Primary Completion: January 18, 2021
• Study Completion: January 18, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

BR (1)