Er:YAG Laser for Dental Cavity Preparation

NCT07831720 | Not Yet Recruiting

• 1 other identifier: 24955-UMP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Caries

Keywords

Er:YAG laser; Dental cavity preparation; Split-mouth study; Class I cavity; Microleakage; Scanning electron microscopy; Patient preference; Restorative dentistry

Outcome Measures

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.

  Immediately after each cavity preparation procedure at each of the two treatment visits

Secondary Outcomes (10)

• Treatment Procedure Time

  Periprocedural, from the start to the completion of cavity preparation at each of the two treatment visits.

• Heart Rate During Cavity Preparation

  Immediately before and during each cavity preparation procedure

• Participant Treatment Preference

  Immediately after the second treatment visit, approximately 1 week after the first treatment visit.

• Presence of Cavity Surface Burning on SEM

  Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction

• Presence of Cavity Surface Carbonization on SEM

  Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction

Study Arms (2)

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.

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.

Procedure: Conventional Rotary Cavity Preparation

Interventions

Er:YAG Laser PROCEDURE

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.

Er:YAG Laser Cavity Preparation

Conventional Rotary Cavity Preparation PROCEDURE

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.

Conventional Rotary Cavity Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ho Chi Minh City Odonto-Stomatology Hospital: lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (1)

Ho Chi Minh City Odonto-Stomatology Hospital

Ho Chi Minh City, Ho Chi Minh City, 71011, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 33114249 BACKGROUND

• Tao 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.

  PMID: 29197434 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Patient Preference

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Van TT Nguyen, MSc

  Ho Chi Minh City Odonto-Stomatology Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Van TT Nguyen, MSc

CONTACT

+84 918883700; ntthaovan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and the treating clinician will not be masked because of the obvious procedural differences between Er:YAG laser and conventional rotary instrumentation. For the ex vivo microleakage assessment, two examiners blinded to the cavity preparation method will independently evaluate dye penetration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)