Effect of spongy gelatin membrane containing nanocurcumin and nanohydroxyapatite on bone regeneration and improvement the soft tissue quality in extracted socket: A Clinical Trial
Effect of spongy gelatin membrane containing nanocurcumin and nanohydroxyapatite on bone regeneration and improvement the soft tissue quality in extracted socket: A Clinical Trial
Design
Clinical trial with control group, with parallel groups on 20 patients
Settings and conduct
Patients who have split mouth extractions on both sides of the mouth, on the intervention side, the membrane containing nanocurcumin and nanohydroxyapatite inside the cavity and on the control side without membrane, according to routine surgeries, no substance will be placed in the cavity. And then, in the second month after the surgery, the patient will refer to the radiograph to check the area.
Participants/Inclusion and exclusion criteria
Entry criteria: patients who need early implants who have healthy buccal and palatal plates. Regarding the health of the buccal and palatal plates, after making sure that the tooth is not retained and explaining it to the patient, a CBCT radiograph is requested from the patient.
Exit criteria:
Patients with broken buccal or palatal plate during tooth extraction;
Patients with periapical lesion;
People with very poor oral hygiene;
smokers;
Alcoholic people;
People with diabetes;
People with high blood pressure;
Other systemic diseases;
Patients with age less than 18 years or more than 50 years
Intervention groups
Intervention group: patients who had split mouth extractions on both sides of the mouth, on the intervention side, a membrane containing nanocurcumin and nanohydroxyapatite inside the socket.
Control group: patients who had split mouth extractions on both sides of the mouth, and on the control side, according to routine surgeries, no material will be placed in the socket.
Main outcome variables
Bone growth and soft tissue repair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048756N5
Registration date:2022-12-13, 1401/09/22
Registration timing:prospective
Last update:2022-12-13, 1401/09/22
Update count:0
Registration date
2022-12-13, 1401/09/22
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2024-03-04, 1402/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spongy gelatin membrane containing nanocurcumin and nanohydroxyapatite on bone regeneration and improvement the soft tissue quality in extracted socket: A Clinical Trial
Public title
Effect nanocurcumin and nanohydroxyapatite on bone regeneration and improvement the soft tissue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need early implants who have healthy buccal and palatal plates.
Exclusion criteria:
Patients with broken buccal or palatal plate during tooth extraction
Patients with periapical lesion
People with very poor oral hygiene
smokers
People with diabetes
Alcoholic people
People with high blood pressure
Other systemic diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.TBZMED.REC.1401.420
Health conditions studied
1
Description of health condition studied
bone defects
ICD-10 code
K06
ICD-10 code description
Other disorders of gingiva and edentulous alveolar ridge
Primary outcomes
1
Description
Bone growth and soft tissue repair
Timepoint
Two months after placing the membranes
Method of measurement
Radiographic imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients who had split mouth extractions on both sides of the mouth, on the intervention side, a membrane containing nanocurcumin and nanohydroxyapatite inside the socket.
Category
Treatment - Other
2
Description
Control group: patients who had split mouth extractions on both sides of the mouth, and on the control side, according to routine surgeries, no material will be placed in the socket.
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
Javad Yazdani
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
maleki.s.89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Street address
Golgasht St, Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Vice Chancellor for Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
research-vice@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
Javad Yazdani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
maleki.s.89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
maleki.s.89@gmai.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be published as an article.
When the data will become available and for how long
After the final publication of the article resulting from the data.
To whom data/document is available
Public
Under which criteria data/document could be used
For use in research articles and systematic reviews with citation.
From where data/document is obtainable
Dr. Solmaz Maleki Dizaj, Tabriz Faculty of Dentistry
What processes are involved for a request to access data/document