Protocol summary
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Study aim
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Investigating the effect of self-assembling peptide nanofiber on the repair of the jaw bone
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Design
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This study will be performed in a phase 2 clinical trial and double-blind. The doctor and statistical specialist will not be aware of the materials and groups. The sample size will be 12 people. According to calculations at Sealedenvelop.com, the selected rendering will be done in 6 groups of 2. Parallel groups include 1- Self-assembled nanofiber peptide group 2- PBS
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Settings and conduct
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Sampling and surgeries will be performed at the Tehran University of Medical Sciences. After tooth extraction and implantation of biomaterials, on the first day, 7 and 14 using the oral scanner in terms of :
1. infection
2. The amount of soft tissue formation
They will be studied in comparison with the control group. Then, after 8 weeks, the amount of bone regeneration in the area will be evaluated using CBCT. Physicians and statisticians will not be aware of the materials and groups.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria
1. Age 18 to 70 years
2. Gender: male and female
3. They need tooth extraction
4. The patient has oral and dental hygiene
Exclusion Criteria
1. Alcohol consumption
2. Pregnancy and breastfeeding
3. Uncontrolled diabetes
4. Autoimmune diseases
5.Cancer and undergoing chemotherapy
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Intervention groups
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1. An osteogenic cocktail of self-assembling peptide nanofiber (the company-made)
2. PBS
is placed in a single dose (0.5 cc) to repair the tooth-extracted cavity and is investigated for 2 months.
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Main outcome variables
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1. Infection
2. The amount of soft tissue formation
3. Bone regeneration
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210526051407N2
Registration date:
2022-07-28, 1401/05/06
Registration timing:
prospective
Last update:
2022-12-09, 1401/09/18
Update count:
1
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Registration date
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2022-07-28, 1401/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-01, 1401/05/10
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Expected recruitment end date
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2023-08-01, 1402/05/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical Trial evaluation of alveolar bone repair using self-assembling peptide nanofiber
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Public title
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Bone regeneration uing self-assembling peptide nanofiber
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient has good oral and dental hygiene
Patient will require tooth extraction
Exclusion criteria:
Alcohol consumption
Pregnancy and lactation
Uncontrolled diabetes
Autoimmune diseases
Cancer and undergoing chemotherapy
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
12
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Selective randomization will be performed based on calculations at Sealedenvelop.com. Randomization will be done in 6 groups of 2 blocks in the form of A and B according to which patients will receive medication interventions.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding is two-way.
1- The doctor who places the material in the tooth cavity does not know the type of implanted material as a clinical caregiver.
2- The statistical expert who analyzes the results does not know about the groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-26, 1401/05/04
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Ethics committee reference number
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IR.IUMS.REC.1401.355
Health conditions studied
1
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Description of health condition studied
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Bone resorption in the jaw
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ICD-10 code
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M96.6
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ICD-10 code description
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Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate
Primary outcomes
1
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Description
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Infection
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Timepoint
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The Zero, 7th and 14th days
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Method of measurement
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Oral Scanner
2
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Description
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Repair of soft tissue
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Timepoint
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The Zero, 7th and 14th days
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Method of measurement
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Oral Scanner
Secondary outcomes
1
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Description
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Bone Regeneration
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Timepoint
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After 2 months
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Method of measurement
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Cone-beam computed tomography (CBCT)
Intervention groups
1
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Description
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Intervention group: Osteogenic cocktail of self-assembling peptide nanofiber (the company-made) is placed in a single dose (0.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
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Category
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Treatment - Drugs
2
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Description
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Control group: PBS is placed in a single dose (0.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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1400-3-99-22545
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Knowledge enterprise company “Tavakol Pars Biomimetic Technologies Company
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available