Clinical trial NCT06077513: Ti-Mesh Frame Comparison for Alveolar Bone Augmentation
Official title: Human Alveolar Bone Augmentation: Comparison 3-D CAD-CAM Ti-mesh Frame With a Conventional Ti-Mesh Frame Fabricated at Time of Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tooth Loss
Keywords: Conventional Ti-Mesh frame
CAD-CAM printed ti-Mesh frame
Dental implants
3-D Alveolar Bone Augmentation
Surgery time
Post op mesh exposure
Post op bone added
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.

The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.

A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:

1. Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
2. Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.


Eligibility criteria: Inclusion Criteria:

* Partially edentulous
* Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement

Exclusion Criteria:

* Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
* Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
* Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
* Subjects under the direct supervision of the PI
* Smoking more than 10 cigarettes per day
* Uncontrolled diabetes or other metabolic disorders

Primary outcomes:
measure: Bone contour accuracy
timeFrame: 5 months post op
measure: Total surgical time
timeFrame: 2 hours
measure: Surgical exposure time for recipient site
timeFrame: 5 minutes
Secondary outcomes:
measure: Ti-Mesh exposure incidence
timeFrame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
measure: Ti-Mesh exposure size
timeFrame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
measure: Ti-Mesh exposure location
timeFrame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
measure: Percentage of Vital bone
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: BU Goldman School of Dental Medicine, Oral Biology/Periodontics
name: Serge Dibart, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: BU Goldman School of Dental Medicine, Oral Biology/Periodontics
name: Albert M Price, DMD
role: STUDY_DIRECTOR
References: