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

NCT06018701 | Recruiting Early Phase 1 DMC

• 1 other identifier: BluebirdIC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulism

Outcome Measures

Primary Outcomes (7)

• 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

  During each visit of the participant every three (3) months (four times in twelve months), or as requested by the participant, intra-oral x-ray will be taken to evaluate hard tissue. Marginal bone loss, if any will be recorded in millimeters (mm). If additional issue (specially radiolucency) of hard tissue is detected then further evaluation through Cone Beam Computed Tomography (CBCT) Scan will be conducted.

  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

  During each visit of the participant every three months (four times in twelve months), or as requested by the participant, clinical examination including photographs will be conducted to evaluate soft tissue. Additionally Loe and Silness Gingival Index will be used to measure in grades 0 to 3, where Grade 0 means Normal gingiva (natural coral pink gingiva; no inflammation; no discoloration); Grade 1 means Mild Inflammation (slight change in color; slight edema; no bleeding upon probing); Grade 2 means Moderate inflammation (Redness; edema; glazing; bleeding upon probing); and Grade 3 means Severe inflammation (Marked redness and edema; swelling; possible ulceration; tendency to bleed spontaneously).

  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

  During each visit of the participant every three months (four times in twelve months), or as requested by the participant, Quigley and Hein Plaque Index will be used to evaluate oral hygiene through Score 0 to 5, where Score 0 means No Plaque; Score 1 means Flecks of stain on the gingival margin; Score 2 means Definite line of plaque on the gingival margin; Score 3 means Plaque on gingival third of tooth surface; Score 4 means Plaque on almost two thirds of tooth surface; and Score 5 means Plaque on greater than two third of tooth surface.

  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

  During each visit of the participant every three months (four times in twelve months), or as requested by the participant, pain on and around dental device ("dantya nikhan") will be recorded with Visual Analogue Scale through Score 0 to 10, where Score 0 means No Pain; Score 1-3 means Mild Pain; Score 4-5 means Moderate Pain; Score 6-7 means Severe Pain; Score 8-9 means Very Severe Pain; and Score 10 means Worst Pain.

  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

  During each visit of the participant every three months (four times in twelve months), or as requested by the participant, discomfort on and around dental device ("dantya nikhan") will be recorded with Visual Analogue Scale through Score 0 to 10, where Score 0 means No Discomfort; Score 1-3 means Mild Discomfort; Score 4-5 means Moderate Discomfort; Score 6-7 means Severe Discomfort; Score 8-9 means Very Severe Discomfort; and Score 10 means Worst Discomfort.

  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

  During each visit of every three months (four times in twelve months), or as requested by the participant, dislodgment of dental device ("dantya nikhan") will be recorded through Present, Mobile and Absent, where Present means that the dental device has been completely detached from the osteotomy; Mobile means that the dental device is not completely detached, but is mobile; and Absent means that the dental device is neither completely detached from the osteotomy nor is mobile.

  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

  During each visit every three months (four times in twelve months), or as requested by the participant, fracture of dental device ("dantya nikhan") will be recorded through Present and Absent, where Present means that the dental device is fractured or cracked; and Absent means that the dental device is neither fractured nor cracked.

  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.

Study Arms (4)

Maxillary Anterior

EXPERIMENTAL

Dental device will be cemented with PMMA bone cement on group that have missing tooth on maxillary anterior region.

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".

Maxillary Posterior

EXPERIMENTAL

Dental device will be cemented with PMMA bone cement on group that have missing tooth on maxillary posterior region.

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".

Mandibular Anterior

EXPERIMENTAL

Dental device will be cemented with PMMA bone cement on group that have missing tooth on mandibular anterior region.

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".

Mandibular Posterior

EXPERIMENTAL

Dental device will be cemented with PMMA bone cement on group that have missing tooth on mandibular posterior region.

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".

Interventions

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". DEVICE

Dental device is surgically placed and cemented with PMMA bone cement on edentulous region.

Also known as: "Dantya Nikhan" is a generic given "Sanskrit" name, as it is a new invention and does not currently exist publicly.

Mandibular Anterior; Mandibular Posterior; Maxillary Anterior; Maxillary Posterior

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bluebird International Clinic: lead

Study Sites (1)

Bluebird International Clinic

Kathmandu, Bagmati, 44600, Nepal

RECRUITING

Study Officials

• Rabindra Mn Shrestha, MDS

  Kantipur Dental College

  STUDY CHAIR

Central Study Contacts

Parakram Parajuli, DMD

CONTACT

+9779851250250; parakramp@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 31, 2023
• Study Start: September 3, 2024
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-12

Locations

NE (1)