Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05517798 |
| Other study ID # |
MBRUMHS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
September 1, 2024 |
Study information
| Verified date |
August 2022 |
| Source |
Mohammed Bin Rashid University of Medicine and Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Global Burden of Disease Study of 2016 considered oral disease as the most common
noncommunicable disease that affected half of the world population throughout their lifetime.
Dental caries and periodontal diseases may cause pain and discomfort with severe forms of
periodontal diseases causing tooth loss. Periodontal disease and tooth loss were estimated to
be one of the ten causes of Years Lived with Disability. The dimensional changes in the
alveolar ridge following tooth loss have been extensively investigated in the literature. At
six months after tooth loss, a systematic review on bone remodelling showed horizontal and
vertical bone loss of 29-63% and 11-22%, respectively. Such bone loss may complicate
replacement of missing teeth with dental implants.
Dental implant is now a common treatment modality. However, the loss of bone volume may not
allow the placement of dental implant in an optimal position and may subsequently jeopardize
functional and aesthetic implant outcomes. Therefore, the use of bone replacement graft
following tooth extraction, as part of a procedure termed alveolar ridge preservation (ARP),
has increasingly becoming a common treatment protocol to optimize dental implant placement in
the future.
A Cochrane review on ARP has demonstrated that there are no significant differences between
the plethora of synthetic or biologically driven grafting materials used to minimize changes
in width and height of the extraction sockets. Nevertheless, a regenerative agent, known as
enamel matrix derivative (EMD), has gained more attention in regenerative therapy over the
last 20 years. Several studies demonstrated its ability to enhance wound healing, induce new
attachment and promote bone formation in recession and intrabony defects. Over the last two
decades, EMD has been successfully used in the periodontal regeneration of intrabony defects.
EMD has the potential to cause early vascularization and support early bone formation, hence,
it can be considered as a potential regenerative agent for ARP when used with appropriate
carrier material.
Moreover, the majority of studies showed that bone substitutes generally performed well in
small or contained defects compared with non-grafted sites, but there is lack of information
regarding the efficacy of different bone substitute materials in large defects. Short-term
follow-up studies of three to six months have also dominated the literature when the main aim
of the ARP is to develop a site that optimise long-term implant outcomes. Such aim requires
evaluating the long-term performance of dental implants placed in preserved ridges and
reporting patient outcomes in well-conducted randomized controlled trial.
The aim of the present clinical trial is to evaluate the adjunctive use of EMD in promoting
the desired vascularization and bone fill in small and large defects following tooth
extraction and report on the long-term implant and patient outcomes.
Description:
A total of 34 participants, attending Dubai Dental Hospital, will be invited to take part in
this randomized controlled trial. The participants will be randomly allocated to two equal
sized groups (17 per group) using computer-generated numbers:
Control group (C): Xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Wolhusen, Switzerland) +
resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland).
Test group (T): Xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) combined with
EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland) + resorbable collagen membrane
(Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland). The minimally traumatic extraction of
the tooth will include raising a full mucoperiosteal flap and sectioning the roots if
required. This will allow visual assessment of the socket walls and thorough debridement of
the extraction socket. A clinician not involved in the study will then open a sealed opaque
envelope and ARP procedure will be carried out by placing either xenograft (Bio-Oss Collagen,
Geistlich Pharma AG, Switzerland) alone or combined with EMD (Straumann Emdogain, Straumann
AG, Basel, Switzerland). The xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland)
will pre-wetted with blood or saliva prior to applying it to the socket. EMD (Straumann
Emdogain, Straumann AG, Basel, Switzerland) will then be placed into the socket. Xenograft
will not be mized with EMD outside the oral cavity. In both groups, a resorbable collagen
membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland) will be trimmed and adapted
to cover the socket. The flaps will then be replaced and sutured with 4/0 polyglycolic acid
interrupted and mattress sutures.
After six months of healing, CBCT will be utilized in the assessment of the available bone
volume and virtual implant treatment planning. A three-dimensional printed surgical stent
will be fabricated to aid in implant placement. The implant site will then be prepared
according to the surgical protocol outlined in the International Team for Implantology (ITI)
consensus conference. This procedure will include raising a mucoperiosteal flap with slightly
palatal crestal incision and sulcular incision extending to the adjacent teeth. The osteotomy
will be prepared to place a chemically modified, sand-blasted and acid-etched dental
implants. In the presence of peri-implant bone defect, simultaneous contour augmentation will
be carried out. For all implant surgeries, two-stage protocol will be followed with a
re-opening procedure after 12 weeks to place a healing abutment.
Prosthodontic Protocol The restorative phase will be carried out in a partial or complete
digital workflow. Within 21-28 days of placing the healing abutment, the implant position
will be captured using an intraoral optical scanner. Computer-aided design / computer-aided
manufacturing (CAD/CAM) will be utilizing the captured digital data to design a
screw-retained crown, which will then be milled of monolithic lithium disilicate blanks and
bonded to pre-fabricated titanium abutments.
