3D Printed Scaffold Device for Ridge Preservation After Tooth Extraction

NCT03735199 | Completed

• 1 other identifier: CTGCoD-2001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Following tooth extraction, the socket heals naturally with bone in 1 to 2 months. This healing process occurs with substantial reduction of the original height and width of the alveolar ridge. In a significantly resorbed ridge, bone augmentation procedures are necessary before dental implant placement. Autogenous bone is the gold standard for this purpose but the harvesting procedure results in additional morbidities and expenses. Ridge preservation techniques have been introduced, using xenografts, allografts or synthetic materials to fill the tooth socket immediately after extraction. While the current materials used have improved ridge dimensions to various extents, their osteoconductivity is suboptimal and unpredictable. They do not reduce vertical resorption of the bony walls and often interfered with the normal healing process. Polycaprolactone - tricalcium phosphate (PCL-TCP) is a bioactive, bioresorbable composite polymer that is non-toxic and tissue-compatible. This study will test the use of a novel 3D printed PCL-TCP device for ridge preservation, leveraging on its 3D shape that fits snugly in the tooth socket, high porosity and bioactivity to promote osteogenesis and reduce resorption. The hypothesis is that the insertion of a PCL-TCP scaffold in extraction sockets allows normal bone healing and better maintenance of ridge dimensions after 6 months compared to extraction sockets without a space filler. This will be a prospective, randomized controlled clinical trial in patients who require single tooth extraction and replacement with a dental implant. The study will compare the ridge dimensions and the quality and quantity of bone formed in tooth sockets, using histology and microcomputed tomography, in both groups after 6 months. The PCL-TCP scaffold to be used in this study will be fabricated by a local spin-off company, Osteopore International Pte Ltd. The market potential for this device is tremendous due to a growing demand for tooth replacement from an ageing population worldwide.

Conditions

Bone Resorption After Tooth Extraction

Keywords

3D Printed Scaffold Device

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge resorption

  This will be measured indirectly as the vertical distance from each reference marking on the stent to the marginal bone of the tooth socket at the mesio-buccal, mid-buccal and disto-buccal aspects

  6 months post-extraction

Secondary Outcomes (4)

• Quality of bone tissue formed in tooth sockets

  6 months post-extraction

• Quantity of bone tissue formed in tooth sockets

  6 months post-extraction

• Stability of dental implant

  6 months post-extraction

• Healing and inflammatory response in tooth sockets

  6 months post-extraction

Study Arms (2)

PCL-TCP scaffold

EXPERIMENTAL

During the surgery, the PCL-TCP scaffold will be shaped by cutting and shaving with a scalpel so as to fit the extraction socket snugly at the crestal half to two-thirds aspect. A Geistlich Bio-Gide collagen membrane will be placed over the scaffold at the crestal aspect of the socket. The periosteum of the buccal flap will then be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.

Device: PCL-TCP scaffold; Device: Geistlich Bio-Gide collagen membrane

Geistlich Bio-Gide collagen membrane

ACTIVE COMPARATOR

No space filler will be inserted in the extraction socket but similar to the test group, a Geistlich Bio-Gide collagen membrane will be placed over the crestal aspect of the socket and the periosteum of the buccal flap will be incised to allow a tension-free primary closure with 4/0 Vicryl® suture. denture overlying the extraction site will be completely relieved.

Device: Geistlich Bio-Gide collagen membrane

Interventions

PCL-TCP scaffold DEVICE

During the surgery, the scaffold will be shaped by cutting and shaving with a scalpel so as to fit the extraction socket snugly at the crestal half to two-thirds aspect. A collagen membrane will be placed over the scaffold at the crestal aspect of the socket. The periosteum of the buccal flap will then be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.

PCL-TCP scaffold

Geistlich Bio-Gide collagen membrane DEVICE

A collagen membrane will be placed over the crestal aspect of the socket and the periosteum of the buccal flap will be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.

Geistlich Bio-Gide collagen membrane; PCL-TCP scaffold

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be above 21 and below 70 years of age (both inclusive)
• Patient must be of ASA I or ASA II classification
• Patient who requires single tooth extraction
• Patient whose tooth to be extracted is bounded by adjacent teeth
• Patient who is suitable for dental implant therapy after extraction

You may not qualify if:

• Patient with known allergy to biopolymer materials
• Patient who are smokers
• Patient who has undergone therapeutic radiation for head and neck malignant disease
• Maxillary lateral incisor and molars; or mandibular central and lateral incisor extraction sites
• Extraction sites with insufficient vertical bone height for implant placement without additional bone grafting (such as sinus lift procedure)

Sponsors & Collaborators

• National Dental Centre, Singapore: lead
• Osteopore International: collaborator

Study Sites (1)

National Dental Centre Singapore

Singapore, 168938, Singapore

Location

Study Officials

• Bee Tin Goh

  National Dental Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Oral & Maxillofaical Surgery, Clinical Associate Professor, Director of Research, NDCS

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 8, 2018
• Study Start: February 28, 2019
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

SG (1)