Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02703480 |
| Other study ID # |
11877 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2015 |
| Est. completion date |
June 2023 |
Study information
| Verified date |
February 2022 |
| Source |
Tufts University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
E) Study Procedures Visit 1: Screening (Approximately 30 mins) Informed consent will be
obtained by the principal investigator or a co-investigator. The subjects will be instructed
to read the informed consent form (ICF), given ample time to have any questions answered, and
then instructed to sign the ICF. Subject will be given a copy of the ICF.
Subject will be asked to complete demographic information and a medical history.
Inclusion/exclusion criteria will be evaluated.
The pre-operative height of the bony crest will be evaluated on the pre-existing radiographs
from the referring clinic if they are less than 6 months old. If recent radiographs do not
exist, radiographs will be taken at this visit. It is standard of care to have radiographs
from within the past 6 months prior to surgery.
Visit 2: Surgery (Approximately 180 mins) Medical history will be reviewed as standard of
care. Eligibility and subject withdrawal criteria will be reviewed to ensure the subject
still qualifies for the study.
Surgeries will be performed by either of two investigators, Yong Hur (Co-I) and Yumi Ogata
(PI).
The use of d-PTFE for vertical ridge augmentation will be randomly assigned to one side of
the mouth of each subject (randomization is for research purposes) and Ti-mesh to the other
side of mouth, and therefore, subjects will receive both of the following procedures:
- Guided Bone regeneration (GBR) procedure using a d-PTFE: (standard of care excluding
clinical measurements) The following steps will be performed following standard of care
procedures: local anesthesia, muco-periosteal incision, full thickness flap reflection,
de-cortication of the alveolar ridge, bone harvesting using bone scrapers, tenting screw
placement, clinical measurements, DBBM graft material placement, the placement and
stabilization of the d-PTFE membrane according to manufacturer's instructions, sutures.
- Guided Bone regeneration (GBR) procedure using Ti-mesh: (standard of care excluding
clinical measurements) The following steps will be performed following standard of care
procedures: local anesthesia, muco-periosteal incision, full thickness flap reflection,
de-cortication of the alveolar ridge, bone harvesting using bone scrapers, tenting screw
placement, clinical measurements, DBBM graft material placement, the placement and
stabilization of the titanium mesh according to manufacturer's instructions, sutures.
Bone harvesting using bone scrapers will be performed during GBR procedures with both
techniques (d-PTFE and Ti-mesh). Bone harvesting using bone scrapers is for harvesting
particulate autogeneous bone graft material. The investigators will use a mixture of 50:50
DBBM and autogenous bone graft material for all vertical augmentation procedures in the
study. Particulate autogenous bone graft will be harvested from the retromolar region of the
mandible. This area is just next to the area of GBR procedures (posterior mandible) and will
be visible after flap elevation for vertical augmentation. Therefore, the investigators do
not need any additional steps except harvesting autogenous bone graft. Intraoral harvesting
by bone scrapers from the retromolar region is a simple and safe method for collecting
cortical bone chips.
The intrasurgical clinical measurements of the ridge height will be taken during surgery. The
distance between the top of the tenting screw and bone crest will be measured with a
periodontal probe during the procedure. Duration of each procedure and surgical complications
including flap tear and bleeding will be collected. All outcome measurements will be
performed by a Co-I who did not perform the surgery.
The subject will be asked to complete a pain/discomfort survey using VAS scale from zero to
ten. A medication log will be given to the patient to track the number of pills of the
prescribed painkiller they have taken in order to examine the amount of pain after the
surgical procedures. The mean number of pills used after surgical procedures will be
analyzed.
Post-operative medication will be prescribed following TUSDM standard of care guidelines.
Visit 3 (7±3 days after procedure): Post-operative Follow-up (Approximately 20 mins)
Medical history will be reviewed as standard of care. Eligibility and subject withdrawal
criteria will be reviewed to ensure the subject still qualifies for the study.
Each subject will have a post-operative visit, which is standard practice at TUSDM
periodontology clinic. Standard of care procedures including suture removal and evaluation of
surgical site will be performed.
For research, information regarding bleeding, presence of infection, bruising, and/or other
complications will be collected. Each subject will complete a survey to evaluate the level of
pain/discomfort, bleeding, and swelling following the surgical procedure for each side - each
classified on a VAS scale from zero to ten. In addition, the subject will return his or her
completed medication log.
Visit 4 (21±3 days after procedure): Post-operative Follow-up (Approximately 20 mins)
Medical history will be reviewed as standard of care. Eligibility and subject withdrawal
criteria will be reviewed to ensure the subject still qualifies for the study.
Each subject will have a post-operative visit, which is standard practice at TUSDM
periodontology clinic. Standard of care procedures including suture removal and evaluation of
surgical site will be performed.
For research, information regarding bleeding, presence of infection, bruising, and/or other
complications will be collected. Each subject will complete a survey to evaluate the level of
pain/discomfort, bleeding, and swelling following the surgical procedure for each side - each
classified on a VAS scale from zero to ten.
Follow-up visits during the six month post-operative period of the vertical ridge
augmentation surgery will be scheduled. Standard of care procedures and evaluations will be
completed during follow-up visits. The surgical sites will be evaluated after the vertical
ridge augmentation procedures, in order to assess the presence of postoperative
complications, such as the exposure of a d-PTFE membrane or Ti-mesh, infection, swelling,
paresthesia or any other complications. All will be noted in the subject's axiUm record and
reviewed at the time of Visit 4.
Visit 5 (6±1 months after Visit 4): Evaluation visit (Approximately 20 mins) Medical history
will be reviewed as standard of care. Eligibility and subject withdrawal criteria will be
reviewed to ensure the subject still qualifies for the study.
Surgical sites will be evaluated and the subject's axiUm record will be reviewed for any
complications.
Each subject will complete a survey to evaluate the level of pain/discomfort, bleeding, and
swelling following the surgical procedure for each side - each classified on a VAS scale from
zero to ten, as at Visit 3.
Radiographs will be taken. It is standard of care to have radiographs taken prior to implant
placement. The post-operative (after the vertical GBR augmentation procedure) height of the
bony crest will be evaluated on the radiographs taken as part of standard of care.
Visit 6 (Up to 1 month after Visit 5): Bone core harvesting, implant placement visit
(Approximately 120 mins) Medical history will be reviewed as standard of care. Eligibility
and subject withdrawal criteria will be reviewed to ensure the subject still qualifies for
the study.
The subject will present for their regularly scheduled implant placement. The following steps
will be performed following standard of care procedures: local anesthesia, muco-periosteal
incision, full thickness flap reflection, membrane (Ti-mesh/d-PTFE) removal, clinical
measurements, tenting screws removal, bone core harvesting, implant osteotomy, implant
placement, and sutures.
The intrasurgical clinical measurements of the ridge height will be taken at during implant
placement surgery. The distance between the top of the tenting screw and bone crest will be
measured with a periodontal probe during the procedure. The bone height gain will be
calculated by subtracting the second measurement form the first measurement (taken during
initial surgery).
At the time of the implant placement a bone core will be harvested from each site of the
implant locations for histological analysis. For the bone samples in this study, a hollow
(trephine) bur, rather than solid bur, will be used to allow for sampling. A trephine bur
with 3-4 mm diameter will be used. The core size will not exceed the amount of bone removal
required for designated implants. Removal of bone is standard during implant placement in
order to create space for the fixture.
The bone core biopsies will be placed in fixative and labeled with subject ID. The collected
bone samples will be placed in alcohol for storage and stored in a basic science laboratory
DHS-635.
The implant placement will not be considered a part of this study.
After Visit 6 - Laboratory analysis of bone core sample Histological slides will be prepared
and histomorphometric analysis will be performed by the commercial laboratory (CBSET). The
samples will be coded as subject numbers and histological analysis will be blinded. All
collected bone core samples will be shipped to the laboratory (CBSET) by Yumi Ogata (PI) or
Yong Hur (Co-I).
Histomorphometric measurements of the tissue fractions (DBBM, autogenous bone, newly formed
bone and marrow and/or connective tissue) will be performed for the grafted area. The
sections will be digitally photographed with computerized software.
