The Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation (Histological and Radiological examination):Clinical trial
Determining the histological and radiographic effectiveness of demineralized allogenic dentin matrix (ADDM) on healing outcome in maxillary sinus floor augmentation
Design
Clinical trial with a control group, with parallel groups, double-blind, non-randomized
Settings and conduct
In order to prepare allogenic demineralized dentin matrix, teeth with hopeless prognosis (advanced periodontal involvement, non-functioning third molar) and without root filling are extracted. After the removal of cement and enamel, the dentin is divided into particles with a size of 1 to 1.5 mm and undergoes partial demineralization.6 months after the surgery, a sample is taken with a trephine bur. The samples are examined histologically for the amount of remaining graft material and the formation of vital bone. The density and height of the bone in the area is determined by CBCT
Participants/Inclusion and exclusion criteria
Patients referred to the Faculty of Dentistry in Tabriz who are candidates for implant placement with bilateral partial edentulous or complete edentulous posterior maxillary region and maxillary sinus floor lifting surgery. The height of the remaining bone between the alveolar crest and the sinus floor 5
mm or less and it is not possible to place the implant in the posterior region of the maxilla in a single stage.
Intervention groups
On the control side xenograft and on the intervention side, allogeneic demineralized dentin matrix (ADDM) is used.
Main outcome variables
1) Determining and comparing the amount of vital bone formation in patients treated with ADDM and xenograft after 6 months
2) Determination and comparison of radiographic bone density in the posterior maxilla in patients treated with ADDM and xenograft after 6 months
3) Determination and comparison of the radiographic height of the bone in the posterior maxilla in patients treated with ADDM and xenograft after 6 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241127063872N1
Registration date:2025-01-02, 1403/10/13
Registration timing:registered_while_recruiting
Last update:2025-01-02, 1403/10/13
Update count:0
Registration date
2025-01-02, 1403/10/13
Registrant information
Name
Fatemeh Aghaziarati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
faa.ziarati2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation (Histological and Radiological examination):Clinical trial
Public title
Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The height of the remaining bone between the alveolar crest and the sinus floor 5mm or less
Presence of bilateral partial edentulism or complete edentulism in the posterior maxillary region
Exclusion criteria:
Pathological condition involving the sinus (cystic lesions , acute and chronic inflammatory disease and benign and malignant tumors)
Medical conditions known to affect bone metabolism such as osteoporosis
Drug regimen that affects the normal wound healing process ;Such as bisphosphonates and continuous use of corticosteroids
History of chemotherapy or head and neck Radiotherapy at the time of surgery or the next 6 months
Psychological problem that causes the patient's cooperation
Sinus membrane perforation during surgery
Smoking
Pregnant women
Systemic diseases such as uncontrolled diabetes and cardiovascular disease
Presence of untreated periodontal diseases and periapical lesions in the teeth adjacent to the sinus
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
The present study is conducted with split mouth design in patients referred to Tabriz Dental Faculty who are candidates for implant placement and maxillary sinus floor augmentation surgery. Xenograft is used on the control side and allogenic demineralized dentin matrix is used on the test side.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know about control (Xenograft) and test (dentin graft).
In order to blind the surgery, the first stage (dentin graft and Xenograft placement) and the second stage (sample collection and implant placement) will be performed by two surgeons.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research Faculty of Dentistry Tabriz University of Medical Sciences
Street address
TFaculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St, University St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2024-11-18, 1403/08/28
Ethics committee reference number
IR.TBZMED.DENTISTRY.REC.1403.046
Health conditions studied
1
Description of health condition studied
Candidate patients for implant placement in the posterior region of the maxilla and maxillary sinus floor augmentation surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of newly formed vital bone
Timepoint
6 months after maxillary sinus floor augmentation surgery
Method of measurement
Sampling is done with a Trephine bur with a diameter of 7.2 mm at the location of the implants. The collected samples are placed in 10% formalin solution and sent to the laboratory for histological examination. After routine and specific staining (Eosin and Hematoxylin and Red Alizarin), microscopic slides are prepared and after imaging with the help of Motic Image 2 software, the amount of newly formed vital bone is measured in square millimeters.
2
Description
Amount of remaining grafting material
Timepoint
6 months after maxillary sinus floor augmentation surgery
Method of measurement
Sampling is done with a Trephine bur with a diameter of 7.2 mm at the location of the implants. The collected samples are placed in 10% formalin solution and sent to the laboratory for histological examination. After routine and specific staining (Eosin and Hematoxylin and Red Alizarin), microscopic slides are prepared and after imaging with the help of Motic Image 2 software, the amount of the remaining graft material is measured in square millimeters.
3
Description
Bone density
Timepoint
6 months after maxillary sinus floor augmentation surgery
Method of measurement
Based on the Hounsfield number From the CBCT by soft App Mimics 10.01
4
Description
bone height
Timepoint
6 months after maxillary sinus floor augmentation surgery
Method of measurement
The difference in bone height from the crest of the ridge to the bottom of the sinus between before surgery and 6 months after surgery in the patient's CBCT
Secondary outcomes
empty
Intervention groups
1
Description
**Intervention Group:**In the surgical procedure for the intervention group, 2 cc of allogenic demineralized dentin matrix is placed. Teeth with a poor prognosis (such as non-functioning third molars) and no root fillings are extracted. Soft tissue, debris, and cementum on the root surface are removed using a sickle scaler, and the pulp inside the root is extracted with a k-file; enamel is removed with a burr.The remaining dentin is rinsed with sterile saline and processed in a bone mill to create particles sized 1 to 1.5 mm. These particles are washed in a 0.1 M sodium chloride solution, treated with 0.1 M Tris-HCl (pH 7.4) for 10 minutes, and then demineralized in 2% HNO3 (pH 1.0).To acellularize the samples, trypsin, raffinose, and sucrose are used in Hanks buffer. Finally, the samples are washed three times with a PBS solution containing penicillin and streptomycin for 10 minutes each and then disinfected by UV.
Category
Treatment - Surgery
2
Description
Control group: In control surgery Xenograft (Bone +B; Nova Teb Pars, Marzanabad, Iran) is placed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Aghaziarati
Street address
University St., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 913 060 7655
Email
faa.ziarati2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Koohsoltani
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3177 1041
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Aghaziarati
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Sardar Soleimani Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 6977
Email
faa.ziarati2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Aghaziarati
Position
Dental resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Fax
Email
faa.ziarati2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Aghaziarati
Position
Dental resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave., Tabriz university of medical science
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Fax
Email
faa.ziarati2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available