A Clinical Trial of Dental Device Cemented with Polymethyl Methacrylate (PMMA) Bone Cement

Official title

A Clinical Trial of Dental Device Made of Zirconia Cemented with PMMA Bone Cement on Partial Edentulous Patients of Kathmandu

Overview

Conventional bridge and dental implants have been playing a significant role in replacing missing tooth/teeth. But they come with shortcomings. Hence, to explore the possibility of addressing such shortcomings, a clinical trial study of a new dental device made of zirconia is intended to be studied to see if it could serve as an additional option for fixed prosthodontics. An approach to explore possibilities for cheaper and faster procedure with regards to the treatment of tooth/teeth loss.

Detailed description

Objectives:

To determine whether the use of a new dental device made of zirconia cemented with Polymethyl methacrylate (PMMA) bone cement could be an additional option for a faster treatment for missing tooth/teeth with fixed/removable prosthodontics.

Methodology:

After a Cone Beam Computed Tomography (CBCT) scan and clinical evaluation, 48 samples of zirconia dental device will be cemented with PMMA bone cement in edentulous area on randomized population. Immediate loading (0-15 days) with single crown and multiple unit bridge made of zirconia will be cemented using luting cement as fixed restoration. Radiographic evaluation and clinical examination will be conducted every three (3) months for one year.

Expected Outcome:

A new dental device made of zirconia could be an additional option for the treatment of edentulism, which could be completed within 0-15 days with minimal risk.

Interventions

• Device A dental device made of zirconia. This is a new invention and does not exist generically. The given generic name of the invention (dental device) is "Dantya Nikhan".
  Dental device is surgically placed and cemented with PMMA bone cement on edentulous region.

Primary outcome measures

• Marginal bone loss around dental device ("dantya nikhan") measured in millimeters (mm) through intra-oral x-ray and horizontal and vertical bone loss through Cone Beam Computed Tomography (CBCT) Scan [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]
• Gingival status and health around dental device ("dantya nikhan") measured through Loe and Silness Gingival Index as Grade 0 to 3 and will be recorded with photographs [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]
• Oral Hygiene status around dental device ("dantya nikhan") measured through Quigley and Hein Plaque Index as Score 0 to 5 [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]
• Pain on and around dental device ("dantya nikhan") measured through Visual Analogue Scale as Score 0 to 10 [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]
• Discomfort on and around dental device ("dantya nikhan") measured through Visual Analogue Scale as Score 0 to 10 [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]
• Dislodgment of dental device ("dantya nikhan") measured through Present, Mobile and Absent [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]
• Fracture or crack of dental device ("dantya nikhan") measured through Present and Absent [Time frame: Total time frame is 16 months, 48 samples trial is to be completed in 4 months. Each sample will have follow up of 3 months for 12 months. The trial of samples on 4th month will complete the 12 months follow up in the 16th month.]

Eligibility criteria

Inclusion criteria

• Adult patients (18 years old and above) who agrees for the treatment
• Single/multiple missing tooth/teeth (edentulism)
• Maxillary/mandibular bone density of more than 350 Hounsfield Unit (HU)
• Edentulous region with minimum of 2mm bone width and 5mm of bone height
• Well controlled diabetes and hypertension

Exclusion criteria

• Severe/Critical medical conditions
• Adults above 80 years old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Nepal · 1 center

• Bluebird International Clinic — Kathmandu

Identifiers

NCT: NCT06018701 · BluebirdIC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗