Clinical trial NCT06018701: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Edentulism
Lead sponsor: Bluebird International Clinic
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Total forty eight (48) dental devices made of zirconia will be cemented. 12 dental device in each allocated quadrant, i.e., maxillary anterior, maxillary posterior, mandibular anterior and mandibular posterior. And the results will be compared.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: 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
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Oral Hygiene status around dental device ("dantya nikhan") measured through Quigley and Hein Plaque Index as Score 0 to 5
timeFrame: 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.
measure: Pain on and around dental device ("dantya nikhan") measured through Visual Analogue Scale as Score 0 to 10
timeFrame: 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.
measure: Discomfort on and around dental device ("dantya nikhan") measured through Visual Analogue Scale as Score 0 to 10
timeFrame: 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.
measure: Dislodgment of dental device ("dantya nikhan") measured through Present, Mobile and Absent
timeFrame: 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.
measure: Fracture or crack of dental device ("dantya nikhan") measured through Present and Absent
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Bluebird International Clinic
state: Bagmati
Study officials:
affiliation: Kantipur Dental College
name: Rabindra Mn Shrestha, MDS
role: STUDY_CHAIR
References: