Investigating the effectiveness of using pure xenografts for edentulous ridge augmentation
Design
One-arm Clinical trial, phase 2 on at least 15 patients
Settings and conduct
In case of requiring sinus augmentation, the window is outlined by piezosurgery. A collagen membrane is fixed in the most apical part of the vestibular region using fixation tacks. Bovine xenograft is hydrated and applied in the sinus cavity and over the lateral wall of the edentulous ridge. The membrane is extended over the crest to cover the palatal ridge and fixed using additional tacks. The flap is released with periosteal-releasing incisions. The flap margins are coronally displaced with tension-free mattress sutures. Additional simple sutures are applied to ensure complete sealing of the incision site.
Participants/Inclusion and exclusion criteria
The inclusion criteria were partial/complete edentulism of the maxillary ridge with or without the need for maxillary sinus floor augmentation, patients requiring implant-supported fixed dentures, and availability of follow-up data of patients for a minimum of 6 months after edentulous ridge augmentation.
The exclusion criteria were smoking, alcohol consumption, substance abuse, uncontrolled metabolic disorders, untreated periodontal disease, (VI) history of radiotherapy or intake of immunosuppressants, and history of intake of anti-resorptive medications.
Intervention groups
Edentulous maxillary ridge augmentation using pure xenografts
Main outcome variables
Data related to bone width and height are obtained using CBCT images on repeatable cuts with a fixed reference point such as the wall/floor of the nasal cavity/maxillary sinus. Considering the prediction of implant placement subcrestally, the width of the buccolingual ridge will be measured at the level of 2 mm apical to the bony crest.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211122053149N2
Registration date:2023-09-18, 1402/06/27
Registration timing:registered_while_recruiting
Last update:2023-09-18, 1402/06/27
Update count:0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Anahita Moscowchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2314
Email address
a.moscowchi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of xenograft materials in maxillary edentulous ridge augmentation: a clinical study
Public title
Efficacy of pure xenografts in bone augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Partial/complete edentulism of the maxillary ridge with or without the need for maxillary sinus floor augmentation
Patients requiring implant-supported fixed dentures
Availability of follow-up data of patients for a minimum of 6 months after edentulous ridge augmentation.
Exclusion criteria:
Smoking
Alcohol consumption
Substance abuse
Uncontrolled metabolic disorders
Untreated periodontal disease
History of radiotherapy or intake of immunosuppressants
History of intake of anti-resorptive medications
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Blv., Evin, Shahid Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.SBMU.DRC.REC.1402.052
Health conditions studied
1
Description of health condition studied
Horizontal defect in maxillary ridge
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Buccolingual width of the ridge at the level of 2 mm apical to the alveolar crest
Timepoint
Measurement of ridge width at the beginning of treatment and at least 6 months after surgery
Method of measurement
Cone beam computed tomography
Secondary outcomes
1
Description
Ridge height based on a fixed point on the nasal floor or sinus floor
Timepoint
At the beginning of treatment and at least 6 months after surgery
Method of measurement
Cone beam computed tomography
2
Description
Height increase in the sinus area in cases where sinus augmentation would also been performed
Timepoint
At the beginning of treatment and at least 6 months after surgery
Method of measurement
Cone beam computed tomography
Intervention groups
1
Description
Local anesthesia is administered in the maxilla by injection of 4% articaine plus 1:100,000 epinephrine. A mid-crestal incision is made from the most anterior tooth to 5 mm beyond the augmentation area using a 15c surgical scalpel. An oblique releasing incision is made at the mesial end of the first incision and extended beyond the mucogingival line. A full-thickness flap is reflected using a periosteal elevator. In case of requiring maxillary sinus floor augmentation, the lateral window is outlined with a 5 mm distance from the floor and anterior wall of the sinus by piezosurgery. Intentional perforation of cortical bone of the edentulous ridge is performed at 5 mm intervals using a round diamond bur. A barrier membrane of natural collagen (Bio-Gide, Geistlich Biomaterials, Switzerland) is prepared to correspond to the dimensions of the augmentation site and fixed in the most apical part of the vestibular region by using fixation tacks. Bovine xenograft material (Bio-Oss, Geistlich Biomaterials, Switzerland) is hydrated with sterile saline and applied in the sinus cavity and over the lateral wall of the edentulous ridge. The barrier membrane is extended over the crest to cover the palatal wall of the ridge and fixed in place using additional tacks. The flap is released with periosteal-releasing incisions at the flap base, and also by releasing muscle attachments at the vestibular side. The flap margins are coronally displaced with tension-free mattress sutures (poly-glycolic acid). Additional simple sutures are applied to ensure complete sealing of the incision site. Oblique incisions are approximated by using simple single sutures. The sutures are removed after 2 weeks, and the patients are instructed to refrain from using a removable partial denture during the healing period. A minimum of 6 months after surgery, CBCT of the augmented area is requested and the treatment results are assessed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anahita Moscowchi
Street address
Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
Intl_office@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Blvd, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anahita Moscowchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd, Evin, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2314
Fax
Email
a.moscowchi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anahita Moscowchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd, Evin, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2314
Fax
Email
a.moscowchi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anahita Moscowchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjoo Blvd, Evin, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2314
Fax
Email
a.moscowchi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD