Clinical trial NCT03080649: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries, Er:YAG laser, rotary bur
Lead sponsor: Public Dental Health in Uppsala Region
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2017-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective, single-blind, randomized and controlled investigation
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of patients´ experience from baseline - 24 months
timeFrame: 0-24 months
Secondary outcomes:
measure: Change of postoperative complications from baseline - 24 months
timeFrame: 0-24 months
measure: Survival of fillings
timeFrame: 24 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Public Dental Service, Vretgränd 9
Study officials:
References: