Night Guard (3D-Printed) Instructions for Use (IFU)

Overview: This guide provides dental professionals and patients with the essential instructions for use (IFU), cleaning, and adjustment protocols for 3D-printed Night Guards.

Manage Night Guard Indications and Contraindications

The 3D-printed Night Guard is a custom-made dental device crafted from biocompatible materials to protect teeth from damage caused by bruxism (nighttime grinding and clenching).

Contraindications for Use

Patients with the following conditions should not use this device without consulting a dental professional:

• Loose teeth
• Damaged teeth
• Temporomandibular Joint Disorder (TMD)

Understand Risks and Benefits

The 3D-printed Night Guard provides cushioning to prevent tooth damage and relieve discomfort associated with bruxism.

Potential Side Effects

• Mouth or tooth soreness: This is common when first using the device and typically resolves after a few days of use.
• Persistent pain: If the patient experiences ongoing sensitivity or pain, the patient should consult their dental practice immediately.

Configure and Seat the Night Guard

The 3D-printed Night Guard contains softening thermodynamic properties that allow for a comfortable fit with minimal adjustments.

Seat the Splint

1. Heat the splint: Place the Night Guard under hot water for 20–30 seconds before placement to add flexibility.
2. Wash hands: Ensure hands are clean before handling the device.
3. Position device: Place the Night Guard over the upper or lower teeth as instructed by the dentist.
4. Secure fit: Instruct the patient to bite down gently to ensure a comfortable fit.

Apply Adjustments to the Night Guard

When making adjustments to the Night Guard, dental professionals should follow these technical specifications to prevent micro-fractures:

• Speed and Pressure: Operate the bur at high speed with minimal pressure.
• Temperature Control: Use water and air spray constantly to maintain temperature.
• Tool Selection:
  • Fine-grit diamond: Recommended for general adjustments.
  • Football-shaped bur: Best for occlusal and lingual surfaces (especially anterior teeth).
  • Tapered bur: Best for buccal and lingual surfaces.
• Restriction: Do not use air-only handpiece adjustments.

Clean and Store the Night Guard

Daily cleaning is required before and after every use to remove saliva and debris.

Daily Cleaning Steps

1. Rinse immediately: Use warm water (not exceeding 45°C/113°F) after removing the device.
2. Apply soap: Use only soft, antibacterial, uncolored, and unscented liquid dish soap.
3. Rinse thoroughly: Use cool water to remove all soap residue.
4. Morning removal: Rinse the Night Guard with warm water every morning.

Use of Approved Cleaning Agents

For periodic maintenance, patients may use a soft-bristle brush with antibacterial solutions like Polident or Efferdent for 10–15 minutes.

Substances to Avoid

To prevent warping, discoloration, or material damage, do not use:

• Hot water (above 45°C/113°F)
• Mouthwash or alcohol products
• Sodium hypochlorite (chlorine bleach)
• Hydrogen peroxide
• Heavy dyes or scented soaps

Storage Instructions

Store the Night Guard in a dry, clean container whenever it is not in use.

Additional Information

• Clinical studies have shown that the softening thermodynamics of the 3D-printed Nightguard effectively protects the teeth from damage caused by bruxism.
• Patients should consult with your practice if they experience tooth pain or sensitivity, as this may be a sign
  of a more severe underlying issue.
• Patients may experience mouth or tooth soreness when first using the device, which should resolve after a few days.
• Hard/Soft nightguards have a limited warranty, which may vary depending on the manufacturer.

Reference ADA Codes and Safety Data

Use the following codes for insurance reporting and refer to the attached documentation for safety specifications.

ADA Codes

Material Safety and Documentation

• Night Guard Material Safety Data Sheets

Laboratory Supplied IFUs

• Removable Laboratory IFUs