What is this study trying to find out about bruxism?

This study is comparing two types of night guards made by different methods to see how they affect patients with bruxism. Researchers want to learn if 3D-printed splints provide similar comfort and durability as conventional acrylic ones. The study is sponsored by Baskent University to improve management of bruxism symptoms.

Who may be eligible for this bruxism clinical trial?

Adults aged 18 to 25 years with a diagnosis of bruxism may be eligible. Participants should not have used an occlusal splint recently or be undergoing major dental or orthodontic treatments. Ability to wear the splint during sleep for 3 months and attend follow-up visits is also required. Please review eligibility criteria for more details.

Is there any cost to participate in this bruxism clinical trial?

Study-related care, including the splint and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 25Years

All Genders

ID07433725

Clinical Performance of 3D-Printed vs Conventional Acrylic Stabilization Splints for Bruxism and Temporomandibular Disorders

Led by Baskent University · Updated on 2026-02-25

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two methods for making occlusal splints (night guards) in adults diagnosed with bruxism, which includes teeth grinding and clenching. This randomized clinical trial aims to compare a 3D-printed photopolymer resin splint (Voco V-Print) with a conventional acrylic splint to determine if the newer 3D-printed option offers similar patient satisfaction and durability. The study focuses on adults aged 18 to 25 years with bruxism and temporomandibular disorders. Participants will be randomly assigned to receive either a 3D-printed splint or a conventional acrylic splint, both custom-made and adjusted as needed. They will be instructed to wear their assigned splint during sleep for three months, following standardized care and use instructions. The study includes a follow-up at 3 months to assess outcomes. During the study, patient satisfaction and oral health-related quality of life will be measured using a questionnaire based on the Oral Health Impact Profile (OHIP). The splints will also be scanned with 3D technology at the start and after three months to measure wear by comparing volume loss. These assessments will help researchers understand patient experiences and the clinical durability of each splint type over the short-term period.

CONDITIONS

Brief Title

3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial

Who Can Participate

Age: 18Years - 25Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years or older diagnosed with bruxism based on clinical assessment and patient report
Indication for an occlusal splint and willingness to wear it during sleep for 3 months
Ability to provide written informed consent
Ability to attend scheduled follow-up visits

You will not qualify if you...

Current or recent use of an occlusal splint within the last 6 months
Ongoing orthodontic treatment or planned major dental treatment during the study period
Severe temporomandibular disorder requiring active treatment such as acute pain or limited mouth opening
Extensive untreated dental disease requiring immediate care like severe periodontal disease or multiple untreated caries
Systemic or neurologic conditions or medications that may significantly affect bruxism or neuromuscular function as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive a custom-made occlusal splint, either 3D-printed or conventional acrylic, which they will wear during sleep according to standardized instructions.

1 baseline visit for splint delivery and adjustment

Follow-up

Duration - At the end of 3 months

Participants complete follow-up assessments to evaluate patient satisfaction, oral health-related quality of life, and clinical performance of the splint.

1 follow-up visit

Trial Site Locations

Total: 1 location

Başkent University, Faculty of Dentistry

Ankara, Turkey (Türkiye), 06490

Actively Recruiting

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Research Team

Hale Arıkan Kalaycı, Assistant Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

Frequently Asked Questions

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Published Research Related To This Trial

Development and evaluation of the Oral Health Impact Profile.

G D Slade, A J Spencer

https://pubmed.ncbi.nlm.nih.gov/8193981

The efficacy of occlusal splints in the treatment of bruxism: A systematic review.

Robert S Hardy, Stephen J Bonsor

https://pubmed.ncbi.nlm.nih.gov/33652054

International consensus on the assessment of bruxism: Report of a work in progress.

F Lobbezoo, J Ahlberg, K G Raphael...

https://pubmed.ncbi.nlm.nih.gov/29926505

Clinical Performance of 3D-Printed vs Conventional Acrylic Stabilization Splints for Bruxism and Temporomandibular Disorders

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