Dental CariesNCT03080649
Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings
A study testing excavated with rotary bur and Er:YAG laser in people with Dental Caries, run by Public Dental Health in Uppsala Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- excavated with rotary bur and Er:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2011to 28 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings. A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- excavated with rotary bur, Er:YAG laser
- Keywords
- dental caries, Er:YAG laser, rotary bur
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
excavated with rotary burDevice
One of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur
Er:YAG laserDevice
One of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Rotary bur | Active comparator | Device rotary bur Receives: Device: excavated with rotary bur |
| Er:YAG laser | Experimental | Device Er:YAG laser Receives: Device: Er:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of patients´ experience from baseline - 24 months
questionnaire
Measured: 0-24 months
Secondary outcomes (2)
Change of postoperative complications from baseline - 24 months
questionnaire
Measured: 0-24 months
Survival of fillings
Registration of Ryges evaluation criteria
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start31 Aug 2011
- Primary completion30 Apr 2016
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective, single-blind, randomized and controlled investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Dental Health in Uppsala Region
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Dr Pia Gabre, Public Dental Health in Uppsala Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080649
- Sponsor's protocol ID
- Dnr 2010/200
- Status last verified
- Apr 2018
- First submitted
- 28 Jan 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03080649
- Acronym / sponsor ID
- Dnr 2010/200
- Conditions
- Dental Caries
- Keywords
- dental caries, Er:YAG laser, rotary bur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Public Dental Health in Uppsala RegionUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 31 Aug 2011 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, single-blind, randomized and controlled investigation
| Arm | Type | Receives |
|---|---|---|
| Rotary bur | Active comparator | Device: excavated with rotary burDevice rotary bur |
| Er:YAG laser | Experimental | Device: Er:YAG laserDevice Er:YAG laser |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| excavated with rotary burOne of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur | Device | Rotary bur |
| Er:YAG laserOne of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser | Device | Er:YAG laser |
Primary outcome
Change of patients´ experience from baseline - 24 months
Time frame: 0-24 months
questionnaire
2 secondary outcomes
Change of postoperative complications from baseline - 24 months
Time frame: 0-24 months
Survival of fillings
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No. IPD are not planned to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing excavated with rotary bur and Er:YAG laser in people with Dental Caries, run by Public Dental Health in Uppsala Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of patients´ experience from baseline - 24 months (time frame: 0-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.