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Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
excavated with rotary bur
Er:YAG laser
Sponsored by
Public Dental Health in Uppsala Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring dental caries, Er:YAG laser, rotary bur

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients should be between 15 and 40 years,
  • at least two lesions with primary caries estimated as being of equal size, and needed to be treated, in bite-wing radiographs, and
  • comparable pairs of cavities should be located on either occlusal or approximal surfaces.
  • the lesions should not involve the inner third of the dentin.

Exclusion Criteria:

  • patients with severe general diseases ( ASA>2) (30),
  • cognitive or intellectual disabilities,
  • patients who required sedation or general anaesthesia, and
  • teeth with periapical pathology, a root filling or non-vital teeth.

Sites / Locations

  • Public Dental Service, Vretgränd 9

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rotary bur

Er:YAG laser

Arm Description

Device rotary bur

Device Er:YAG laser

Outcomes

Primary Outcome Measures

Change of patients´ experience from baseline - 24 months
questionnaire

Secondary Outcome Measures

Change of postoperative complications from baseline - 24 months
questionnaire
Survival of fillings
Registration of Ryges evaluation criteria

Full Information

First Posted
January 28, 2017
Last Updated
April 3, 2018
Sponsor
Public Dental Health in Uppsala Region
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03080649
Brief Title
Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings
Official Title
Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 31, 2011 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Dental Health in Uppsala Region
Collaborators
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the excavation time, patients´ experiences, pulpal reactions and survival of fillings when carious tissue was removed with Er:YAG laser compared to rotary bur. A prospective, single-blind, randomized and controlled investigation was performed. Patients with at least two primary caries lesions radiographically assessed as the same size were recruited. In each patient one cavity was excavated with rotary bur and one with Er:YAG laser technique. The time requested for excavation and local anaesthesia were measured. The prevalence of postoperative symptoms, pulpal vitality and the quality of fillings will be investigated during two years after the excavation occasion.
Detailed Description
The study is a prospective, single-blind, randomized and controlled investigation. Patients between 15-40 years with at least two primary caries lesions radiographically assessed as the same size were recruited. In each patient one cavity was excavated with rotary bur and one with Er:YAG laser technique after a randomized allocation of the lesions to one of the intervention methods. The time requested for excavation to hard/firm dentin and local anaesthesia were measured. Directly after each treatment a questionnaire focusing on the experiences of the current treatment and if the laser method will be chosen in the future was answered. Postoperative pain was measured with a questionnaire one week after the treatment. Six, 12 and 24 months after the fillings were made an evaluation of pulpal status and the quality of the fillings will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, Er:YAG laser, rotary bur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
prospective, single-blind, randomized and controlled investigation
Masking
Outcomes Assessor
Masking Description
The outcome assessor have not met the patient before assessing the outcome. No information about which excavation method used is available.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotary bur
Arm Type
Active Comparator
Arm Description
Device rotary bur
Arm Title
Er:YAG laser
Arm Type
Experimental
Arm Description
Device Er:YAG laser
Intervention Type
Device
Intervention Name(s)
excavated with rotary bur
Intervention Description
One of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur
Intervention Type
Device
Intervention Name(s)
Er:YAG laser
Intervention Description
One of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser
Primary Outcome Measure Information:
Title
Change of patients´ experience from baseline - 24 months
Description
questionnaire
Time Frame
0-24 months
Secondary Outcome Measure Information:
Title
Change of postoperative complications from baseline - 24 months
Description
questionnaire
Time Frame
0-24 months
Title
Survival of fillings
Description
Registration of Ryges evaluation criteria
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients should be between 15 and 40 years, at least two lesions with primary caries estimated as being of equal size, and needed to be treated, in bite-wing radiographs, and comparable pairs of cavities should be located on either occlusal or approximal surfaces. the lesions should not involve the inner third of the dentin. Exclusion Criteria: patients with severe general diseases ( ASA>2) (30), cognitive or intellectual disabilities, patients who required sedation or general anaesthesia, and teeth with periapical pathology, a root filling or non-vital teeth.
Facility Information:
Facility Name
Public Dental Service, Vretgränd 9
City
Uppsala
ZIP/Postal Code
SE-75017
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD are not planned to be shared

Learn more about this trial

Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings

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