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Completed

NCT Number: NCT03080649

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

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.

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Dental Service, Vretgränd 9

Uppsala, SE-75017, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

excavated with rotary bur

Device

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

Primary outcomes

  1. Change of patients´ experience from baseline - 24 months

    Time frame: 0-24 months

    questionnaire

Secondary outcomes

  1. Change of postoperative complications from baseline - 24 months

    Time frame: 0-24 months

    questionnaire

  2. Survival of fillings

    Time frame: 24 months

    Registration of Ryges evaluation criteria

Sponsors and collaborators

Lead sponsor

Public Dental Health in Uppsala Region

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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