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

Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings. A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: excavated with rotary bur; Device: Er:YAG laser

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-75017
    • Public Dental Service, Vretgränd 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rotary bur; Device rotary bur	Device: excavated with rotary bur; One of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur
Experimental: Er:YAG laser; Device Er:YAG laser	Device: Er:YAG laser; One of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of patients´ experience from baseline - 24 months	questionnaire	0-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of postoperative complications from baseline - 24 months	questionnaire	0-24 months
Survival of fillings	Registration of Ryges evaluation criteria	24 months

Collaborators and Investigators

• Sponsor: Public Dental Health in Uppsala Region
• Collaborators: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2011
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: dental caries, Er:YAG laser, rotary bur
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Dnr 2010/200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD are not planned to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No