Er:YAG Laser for Dental Cavity Preparation
ConditionDental Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHo Chi Minh City Odonto-Stomatology Hospital
About this trial
The goal of this clinical trial is to compare Er:YAG laser cavity preparation with conventional rotary instruments in adults who have permanent premolars planned for extraction as part of orthodontic treatment.
The main questions the study aims to answer are:
How do Er:YAG laser and conventional rotary instruments compare in the time needed for cavity preparation? Do participants experience different levels of pain with the two methods? Which cavity preparation method do participants prefer after experiencing both methods? Are there differences in cavity surface and interface characteristics and microleakage between teeth prepared with the two methods?
Researchers will compare Er:YAG laser cavity preparation with conventional rotary cavity preparation using a split-mouth design. Each participant will receive both treatment methods on two different eligible permanent premolars.
Participants will:
Have one eligible premolar prepared with an Er:YAG laser and another eligible premolar prepared with conventional rotary instruments.
Have the two procedures performed at separate visits on different days. Rate their pain after each procedure and indicate which treatment method they would prefer for future dental treatment.
Have the study teeth extracted approximately 1 month later, as already planned for their orthodontic treatment.
After extraction, the teeth will be examined in the laboratory to compare cavity surface and interface characteristics and microleakage between the two preparation methods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult participants with permanent maxillary or mandibular premolars scheduled for extraction for orthodontic reasons.
Eligible premolars are intact or have carious lesions limited to the enamel and are free of pain symptoms.
Where carious lesions are present, teeth meet the study eligibility criteria based on ICDAS II 2009, as specified in the study protocol.
Participants voluntarily agree to participate and provide informed consent.
Disqualifiers
Participants with psychological or behavioral conditions that prevent adequate cooperation with the study procedures.
Teeth showing radiographic evidence of internal root resorption or pulp canal calcification.
Trial design
Design model
Parallel
Treatments tested in this trial
Er:YAG Laser
Procedure/SurgeryClass I cavity preparation will be performed using an Er:YAG laser with a non-contact handpiece in QSP mode for hard-tissue cavity preparation. Residual carious tissue will be checked with a caries detector and additional preparation performed if needed. The cavity will then be restored with composite resin according to the study protocol.
Conventional Rotary Cavity Preparation
Procedure/SurgeryClass I cavity preparation will be performed using conventional rotary instrumentation with a water-cooled diamond bur. Residual carious tissue will be checked with a caries detector and additional preparation performed if needed. The cavity will then be restored with composite resin according to the study protocol.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Er:YAG Laser Cavity PreparationExperimental treatment 1 intervention
Group B: Conventional Rotary Cavity PreparationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity During Cavity Preparation
Participant-reported pain intensity will be assessed immediately after each cavity preparation procedure using the Wong-Baker pain scale, ranging from 0 to 10, with higher scores indicating greater pain. Pain scores after Er:YAG laser cavity preparation and conventional rotary cavity preparation will be compared within participants.
Time frame
Immediately after each cavity preparation procedure at each of the two treatment visitsSecondary outcomes
1
Treatment Procedure Time
The duration of the treatment procedure using each cavity preparation method will be recorded in seconds using a stopwatch. Procedure times for Er:YAG laser and conventional rotary instrumentation will be compared within participants.
Time frame
Periprocedural, from the start to the completion of cavity preparation at each of the two treatment visits.2
Heart Rate During Cavity Preparation
Heart rate will be measured using a finger pulse monitoring device before and during each cavity preparation procedure and recorded in beats per minute. Heart rate measurements associated with Er:YAG laser and conventional rotary cavity preparation will be compared.
Time frame
Immediately before and during each cavity preparation procedure3
Participant Treatment Preference
After experiencing both cavity preparation methods, participants will indicate whether they prefer Er:YAG laser cavity preparation or conventional rotary cavity preparation for future dental treatment.
Time frame
Immediately after the second treatment visit, approximately 1 week after the first treatment visit.4
Presence of Cavity Surface Burning on SEM
Presence or absence of surface burning will be assessed on extracted study teeth using scanning electron microscopy (SEM) and compared between Er:YAG laser-prepared and conventional rotary-prepared cavities.
Time frame
Approximately 1 month after cavity preparation, following orthodontically indicated tooth extractionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ho Chi Minh City Odonto-Stomatology Hospital
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborator
Source ClinicalTrials.gov
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