Dental CariesNCT07831720
Er:YAG Laser for Dental Cavity Preparation
A study testing Er:YAG Laser and Conventional Rotary Cavity Preparation in people with Dental Caries, run by Ho Chi Minh City Odonto-Stomatology Hospital at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Er:YAG Laser and Conventional Rotary Cavity Preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- No spontaneous or continuous dental pain.
- Clinical examination, thermal pulp testing, and electric pulp testing are consistent with normal pulp status.
- Radiographic examination shows no periapical radiolucency and complete root apex formation.
- Participants have no systemic health condition that could adversely affect healing.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Ho Chi Minh City Odonto-Stomatology Hospital
Ho Chi Minh City, Ho Chi Minh City, 71011
Van TT Nguyen, MSc, +84 918883700, ntthaovan@gmail.com
Van TT Nguyen, MSc
About this study
Official title: Safety and Effectiveness of Er:YAG Laser in Cavity Preparation
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:
Read more
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.
Read the detailed description
This is an interventional, split-mouth study designed to evaluate the safety and effectiveness of Er:YAG laser cavity preparation compared with conventional rotary instrumentation.
Adult participants undergoing orthodontic treatment who have permanent premolars scheduled for extraction will be enrolled. Two eligible permanent premolars from each participant will be included. A Class I cavity will be prepared using an Er:YAG laser in one tooth and conventional rotary instruments in the other tooth. Both procedures will be performed by the same dentist at separate visits on different days.
Clinical assessments will include the time required for cavity preparation, pain experienced immediately after each procedure, changes in pulse rate during treatment, and the participant's preferred treatment method after experiencing both techniques.
Following cavity preparation, the teeth will be restored with composite resin. Approximately one month later, the study teeth will be extracted according to the participant's pre-existing orthodontic treatment plan. The extracted teeth will then undergo ex vivo laboratory evaluation.
Selected specimens will be examined using scanning electron microscopy to assess cavity and tooth-restoration interface characteristics. Laboratory evaluation will also assess microleakage between the two cavity preparation methods.
The study will compare the clinical acceptability and ex vivo characteristics of Er:YAG laser cavity preparation with those of conventional rotary cavity preparation.
- Conditions
- Dental Caries
- Being tested
- Er:YAG Laser, Conventional Rotary Cavity Preparation
- Keywords
- Er:YAG laser, Dental cavity preparation, Split-mouth study, Class I cavity, Microleakage, Scanning electron microscopy, Patient preference, Restorative dentistry
- Medical subject headings
- Dental Caries, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG LaserProcedure or surgery
Class 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 PreparationProcedure or surgery
Class 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.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG Laser Cavity Preparation | Experimental | One eligible permanent premolar from each participant will undergo Class I cavity preparation using an Er:YAG laser. Each participant will also receive conventional rotary cavity preparation on another eligible permanent premolar as part of the split-mouth design. Receives: Procedure: Er:YAG Laser |
| Conventional Rotary Cavity Preparation | Active comparator | Another eligible permanent premolar from each participant will undergo Class I cavity preparation using conventional rotary instrumentation. Each participant will also receive Er:YAG laser cavity preparation on another eligible permanent premolar as part of the split-mouth design. Receives: Procedure: Conventional Rotary Cavity Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after each cavity preparation procedure at each of the two treatment visits
Secondary outcomes (10)
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.
Measured: Periprocedural, from the start to the completion of cavity preparation at each of the two treatment visits.
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.
Measured: Immediately before and during each cavity preparation procedure
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.
Measured: Immediately after the second treatment visit, approximately 1 week after the first treatment visit.
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.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Presence of Cavity Surface Carbonization on SEM
Presence or absence of carbonization will be assessed using scanning electron microscopy on extracted study teeth and compared between the two cavity preparation methods.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Presence of Cavity Margin Cracks on SEM
Presence or absence of cracks at the cavity margins will be assessed using scanning electron microscopy and compared between Er:YAG laser and conventional rotary cavity preparation.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Hybrid Layer Thickness
Hybrid layer thickness will be measured in micrometers using scanning electron microscopy on extracted study teeth and compared between the two cavity preparation methods.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Adhesive Layer Thickness
Adhesive layer thickness will be measured in micrometers using scanning electron microscopy on extracted study teeth and compared between the two cavity preparation methods.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Partially Demineralized Dentin Zone Thickness
The thickness of the partially demineralized dentin zone will be measured in micrometers using scanning electron microscopy and compared between Er:YAG laser and conventional rotary cavity preparation.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Microleakage Dye Penetration
Microleakage will be quantified as dye penetration depth in micrometers. Extracted teeth will be examined under polarized light microscopy at 40× magnification, and dye penetration will be measured using NIS-Elements software.
Measured: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth within-participant design. Each participant will receive both cavity preparation methods on two different permanent premolars at separate visits. One premolar will undergo cavity preparation with an Er:YAG laser, and the other premolar will undergo preparation with conventional rotary instruments. Each participant will serve as their own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ho Chi Minh City Odonto-Stomatology Hospital
- Sponsor type
- Other government
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Responsible party
- Sponsor
- Investigators
- Van TT Nguyen, MSc, Principal investigator, Ho Chi Minh City Odonto-Stomatology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831720
- Sponsor's protocol ID
- 24955-UMP
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Participant information will be coded to protect confidentiality, and study results will be reported without identifying individual participants.
Publications
Cardoso M, Coelho A, Lima R, Amaro I, Paula A, Marto CM, Sousa J, Spagnuolo G, Marques Ferreira M, Carrilho E. Efficacy and Patient's Acceptance of Alternative Methods for Caries Removal-a Systematic Review. J Clin Med. 2020 Oct 23;9(11):3407. doi: 10.3390/jcm9113407.
PubMed 33114249Tao S, Li L, Yuan H, Tao S, Cheng Y, He L, Li J. Erbium Laser Technology vs Traditional Drilling for Caries Removal: A Systematic Review with Meta-Analysis. J Evid Based Dent Pract. 2017 Dec;17(4):324-334. doi: 10.1016/j.jebdp.2017.05.004. Epub 2017 May 18.
PubMed 29197434
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Er:YAG Laser in Cavity Preparation
- ClinicalTrials.gov ID
- NCT07831720
- Acronym / sponsor ID
- 24955-UMP
- Conditions
- Dental Caries
- Keywords
- Er:YAG laser, Dental cavity preparation, Split-mouth study, Class I cavity, Microleakage, Scanning electron microscopy, Patient preference, Restorative dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ho Chi Minh City Odonto-Stomatology HospitalOther government
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Sep 2026 (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 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.
Detailed description
This is an interventional, split-mouth study designed to evaluate the safety and effectiveness of Er:YAG laser cavity preparation compared with conventional rotary instrumentation.
Adult participants undergoing orthodontic treatment who have permanent premolars scheduled for extraction will be enrolled. Two eligible permanent premolars from each participant will be included. A Class I cavity will be prepared using an Er:YAG laser in one tooth and conventional rotary instruments in the other tooth. Both procedures will be performed by the same dentist at separate visits on different days.
Clinical assessments will include the time required for cavity preparation, pain experienced immediately after each procedure, changes in pulse rate during treatment, and the participant's preferred treatment method after experiencing both techniques.
Following cavity preparation, the teeth will be restored with composite resin. Approximately one month later, the study teeth will be extracted according to the participant's pre-existing orthodontic treatment plan. The extracted teeth will then undergo ex vivo laboratory evaluation.
Selected specimens will be examined using scanning electron microscopy to assess cavity and tooth-restoration interface characteristics. Laboratory evaluation will also assess microleakage between the two cavity preparation methods.
The study will compare the clinical acceptability and ex vivo characteristics of Er:YAG laser cavity preparation with those of conventional rotary cavity preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth within-participant design. Each participant will receive both cavity preparation methods on two different permanent premolars at separate visits. One premolar will undergo cavity preparation with an Er:YAG laser, and the other premolar will undergo preparation with conventional rotary instruments. Each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser Cavity Preparation | Experimental | Procedure: Er:YAG LaserOne eligible permanent premolar from each participant will undergo Class I cavity preparation using an Er:YAG laser. Each participant will also receive conventional rotary cavity preparation on another eligible permanent premolar as part of the split-mouth design. |
| Conventional Rotary Cavity Preparation | Active comparator | Procedure: Conventional Rotary Cavity PreparationAnother eligible permanent premolar from each participant will undergo Class I cavity preparation using conventional rotary instrumentation. Each participant will also receive Er:YAG laser cavity preparation on another eligible permanent premolar as part of the split-mouth design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- No spontaneous or continuous dental pain.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Er:YAG LaserClass 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. | Procedure or surgery | Er:YAG Laser Cavity Preparation |
| Conventional Rotary Cavity PreparationClass 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. | Procedure or surgery | Conventional Rotary Cavity Preparation |
Primary outcome
Pain Intensity During Cavity Preparation
Time frame: Immediately after each cavity preparation procedure at each of the two treatment visits
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.
10 secondary outcomes
Treatment Procedure Time
Time frame: Periprocedural, from the start to the completion of cavity preparation at each of the two treatment visits.
Heart Rate During Cavity Preparation
Time frame: Immediately before and during each cavity preparation procedure
Participant Treatment Preference
Time frame: Immediately after the second treatment visit, approximately 1 week after the first treatment visit.
Presence of Cavity Surface Burning on SEM
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Presence of Cavity Surface Carbonization on SEM
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Presence of Cavity Margin Cracks on SEM
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Hybrid Layer Thickness
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Adhesive Layer Thickness
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Partially Demineralized Dentin Zone Thickness
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Microleakage Dye Penetration
Time frame: Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 33114249Cardoso M, Coelho A, Lima R, Amaro I, Paula A, Marto CM, Sousa J, Spagnuolo G, Marques Ferreira M, Carrilho E. Efficacy and Patient's Acceptance of Alternative Methods for Caries Removal-a Systematic Review. J Clin Med. 2020 Oct 23;9(11):3407. doi: 10.3390/jcm9113407.
- Background: PubMed 29197434Tao S, Li L, Yuan H, Tao S, Cheng Y, He L, Li J. Erbium Laser Technology vs Traditional Drilling for Caries Removal: A Systematic Review with Meta-Analysis. J Evid Based Dent Pract. 2017 Dec;17(4):324-334. doi: 10.1016/j.jebdp.2017.05.004. Epub 2017 May 18.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Participant information will be coded to protect confidentiality, and study results will be reported without identifying individual participants.
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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.
Van TT Nguyen, MSc principal investigator
Ho Chi Minh City Odonto-Stomatology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG Laser and Conventional Rotary Cavity Preparation in people with Dental Caries, run by Ho Chi Minh City Odonto-Stomatology Hospital at 1 site in Vietnam.
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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Van TT Nguyen, MSc (+84 918883700, ntthaovan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Cavity Preparation (time frame: Immediately after each cavity preparation procedure at each of the two treatment visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07831720, which also lists 2 linked publications.
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 21 Sep 2026.