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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03080649
Enrollment
25
Registered
2017-03-15
Start date
2011-08-31
Completion date
2018-03-28
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, Er:YAG laser, rotary bur

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.

Interventions

DEVICEexcavated with rotary bur

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

DEVICEEr:YAG laser

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

Sponsors

Göteborg University
CollaboratorOTHER
Public Dental Health in Uppsala Region
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention model description

prospective, single-blind, randomized and controlled investigation

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of patients´ experience from baseline - 24 months0-24 monthsquestionnaire

Secondary

MeasureTime frameDescription
Change of postoperative complications from baseline - 24 months0-24 monthsquestionnaire
Survival of fillings24 monthsRegistration of Ryges evaluation criteria

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026