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Dental Cement in Post-operative Sensitivity: Randomized Clinical Trial

NCT04870294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-03

No results posted yet for this study

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

Interventions

DEVICE

Teeth treated with composite resin, control group

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

DEVICE

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

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

Sponsors & Collaborators

  • Universidade do Vale do Sapucai

    lead OTHER

Principal Investigators

  • José Dias Silva Neto · Universidade do Vale do Sapucaí

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
20 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2021-01-18
Completion
2021-01-18

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04870294 on ClinicalTrials.gov