Comparing the Efficacy and Morbidity of Two Vertical Ridge Augmentation Techniques

NCT02703480 | Active Not Recruiting Results

• 1 other identifier: 11877
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.

Conditions

Vertical Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Changes in Vertical Bone Height

  intrasurgical clinical measurement in millimeter

  from 6 months to 8 months following the procedure

Secondary Outcomes (2)

• Rate of Post-Operative Complications

  Up to 6 months to 8 months following the procedure

• Bone Core Histology

  from 6 months to 8 months following the procedure

Study Arms (2)

All Study Participants - d-PTFE

EXPERIMENTAL

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.

Biological: d-PTFE

All Study Participants - Ti-mesh

EXPERIMENTAL

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane

Biological: Ti-mesh

Interventions

d-PTFE BIOLOGICAL

high-density polytetrafluoroethylene (d-PTFE) membrane

All Study Participants - d-PTFE

Ti-mesh BIOLOGICAL

Titanium mesh

All Study Participants - Ti-mesh

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Non-smokers
• Existence of bilateral vertical/horizontal ridge deformities (Seibert Class III)
• The length of the edentulous span is from two or more teeth

You may not qualify if:

• Patients who have an infectious disease (self reported - HIV, tuberculosis or hepatitis)
• Known allergies to the research-related materials
• Patients who have compromised healing potential:
• bone metabolic disease e.g., Paget's disease, osteoporosis, osteomalacia
• uncontrolled diabetes: HbA1c \>=7, values measured within six months (using the existing record in AxiUm or if the subject has the condition, but there is no report in AxiUm - a blood test record will be requested)
• patient currently taking steroid medication
• history of oral bisphosphonate intake greater than 3 years or any IV administration
• Pregnant or lactating patients (self-reported), as part of TUSDM standard of care not to treat for non-emergency surgical procedures
• Presence of surgical scar tissue from previous surgical procedure in the posterior mandible
• Pathology present within the alveolar ridges in the posterior mandible, determined clinically or radiographically
• History of radiation therapy to the mandible
• Smokers
• Elective periodontal procedures are postponed during pregnancy, active infectious disease, bisphosphonate intake or uncontrolled diabetes as standard of care in the TUSDM department of periodontology. Diseases or conditions which have been shown to affect healing are excluded for research. Vertical ridge augmentation is not contraindicated with pregnancy and there is no known safely issues associated with it.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Results Point of Contact

• Title: Associate Professor
• Organization: Tufts University School of Dental Medicine

yumi.ogata@tufts.edu

6176366659

Study Officials

• Yumi Ogata, DMD, DDS, MS

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth study

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: March 9, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2025
• Last Updated: September 4, 2024
• Results First Posted: February 28, 2022

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)