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

NCT03080649 | Completed

• 1 other identifier: Dnr 2010/200
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

dental caries, Er:YAG laser, rotary bur

Outcome Measures

Primary Outcomes (1)

• Change of patients´ experience from baseline - 24 months

  questionnaire

  0-24 months

Secondary Outcomes (2)

• Change of postoperative complications from baseline - 24 months

  0-24 months

• Survival of fillings

  24 months

Study Arms (2)

Rotary bur

ACTIVE COMPARATOR

Device rotary bur

Device: excavated with rotary bur

Er:YAG laser

EXPERIMENTAL

Device Er:YAG laser

Device: Er:YAG laser

Interventions

excavated with rotary bur DEVICE

One of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur

Rotary bur

Er:YAG laser DEVICE

One of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser

Er:YAG laser

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Dental Health in Uppsala Region: lead
• Göteborg University: collaborator

Study Sites (1)

Public Dental Service, Vretgränd 9

Uppsala, SE-75017, Sweden

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor have not met the patient before assessing the outcome. No information about which excavation method used is available.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, single-blind, randomized and controlled investigation

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: March 15, 2017
• Study Start: August 31, 2011
• Primary Completion: April 30, 2016
• Study Completion: March 28, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)