Effects of polytetrafluoroethylene tape on screw access hole sealing of implant-supported fixed dental prostheses

JRCT ID: jRCTs072210057

Registered date:06/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Tooth defect
• Date of first enrollment: 04/09/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Intervention group: Teflon tape is inserted into access holes, and the upper portion is closed with composite resin.
Control group: Cotton ball is inserted into access holes, and the upper portion is closed with composite resin.

Outcome(s)

• Primary Outcome: falling out of filling materials at 12 months after sealing access hole

Secondary Outcome

1. falling out of filling materials at 3, 6, 9 months after sealing access holes
2. insertion/impaction of filling materials at 3, 9, 12 months after sealing access holes
3. Depth (mm) from occlusal surface to filling materials surface at 3, 9, 12 months after sealing access holes
4. Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients who can personally provide written consent at their own free will after being receiving a thorough explanation of the study and fully understanding their participation in the study.
2. Patients who have dental implant prostheses with access holes on the occlusal surface in the posterior region.
3. Dental implant prostheses whose occlusal materials is zirconia or metal (both single crowns and fixed partial dentures)
4. The depth of screw access holes from the upper part of screw to occlusal surface is 4 mm or more by probing (no diameter selective)

Exclude criteria

Any of the following patients will be excluded:
1. Patients with problem in judgement
2. Patients with drug hypersensitivity
3. Patients who are pregnant and lactation period, or planned pregnancy
4. Patients who are participating in another clinical study
5. Patients with screw-retained fixed implant prostheses used as abutment for removal partial denture clasp
6. Patients who are judged as improper to join in this study by the principal investigator or co-investigators

Related Information

• Primary Sponsor: Odatsu Tetsuro