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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080649
• Other study ID #: Dnr 2010/200
• Status: Completed
• Phase: N/A
• First received: January 28, 2017
• Last updated: April 3, 2018
• Start date: August 31, 2011
• Est. completion date: March 28, 2018

Study information

• Verified date: April 2018
• Source: Public Dental Health in Uppsala Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 28, 2018
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Locations

Country	Name	City	State
Sweden	Public Dental Service, Vretgränd 9	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Public Dental Health in Uppsala Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of patients´ experience from baseline - 24 months	questionnaire	0-24 months
Secondary	Change of postoperative complications from baseline - 24 months	questionnaire	0-24 months
Secondary	Survival of fillings	Registration of Ryges evaluation criteria	24 months