Protocol summary

Study aim
Determining the effect of vitamin C on the repair of an extracted tooth socket
Design
A controlled, double-blind, randomized, phase 2 clinical trial on 54 patients. For randomization, random allocation version 1 software was used and for blinding, a placebo similar to vitamin C tablets in similar glass containers was used, where each batch is coded and only the researcher is aware of this coding process
Settings and conduct
This research is single-blind randomized clinical trial study. After examining the patients referred to Periodontology Department of Yazd School of Dentistry according to the entry and exit criteria and obtaining informed consent
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy patients aged 14 to 40 without medical conditions with noninfected bilateral symmetric premolars who require tooth extraction for orthodontic treatment, have no history of smoking or alcohol consumption, women are not pregnant or breastfeeding, patients have no psychiatric disease, and do not use corticosteroids or contraceptives containing estrogen. Exclusion criteria: patients who missed more than 1 dose of vitamin C
Intervention groups
Tooth extraction will be done using a standard technique and under local anesthesia، each extracted wound site is measured 3 times, immediately after extraction, on day 7 and day 21 after extraction In the control group, gel foam impregnated with normal saline and placebo is used, in the systemic drug group, gel foam impregnated with normal saline and 750 mg vitamin C tablets are used, in the topical drug group, gel foam impregnated with 1% vitamin C solution and placebo is used In all 3 groups, the foam gel is inserted into the socket with a 4 zero vicryl suture in a figure eight shape to tighten the gel foam in the area
Main outcome variables
Socket depth; Mesiodistal dimension; Buccolingual dimension; Pharmaceutical group; Age; Sex

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221212056786N1
Registration date: 2023-07-29, 1402/05/07
Registration timing: prospective

Last update: 2023-07-29, 1402/05/07
Update count: 0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Seyed mohammad Arab farashahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 2222
Email address
sm.arab@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vitamin C on the repair of extracted tooth socket
Public title
The effect of vitamin C on the repair of extracted tooth socket
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients aged 14-40 without medical conditions (including the absence of gastrointestinal diseases such as peptic ulcer, etc.) with bilateral symmetrical non-infectious premolars who need tooth extraction for orthodontic treatment. Also have no history of smoking or alcohol consumption Women are not pregnant or breastfeeding Patients do not have psychiatric disorders Patients do not use corticosteroids, anticonvulsant drugs such as phenytoin, contraceptive drugs containing estrogen and other antioxidant supplements in the period close to the study Patients do not have history of allergy to toluidine blue The selected teeth do not have bone loss or defects
Exclusion criteria:
Patients who will miss more than 1 dose of vitamin C
Age
From 14 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the random allocation version 1 software under Windows, we generate a random sequence using a simple random allocation method. The result of the software is in the form of a software that specifies the numbers 1 to 54 along with the letters A, B and C, and the first qualified person will be assigned number 1, and the next people will get numbers 2 to 54. And the researcher places each qualified person in the specified group based on the random allocation table. In order to blind the random allocation, we ask the help of a third person who does not know about the interventions and the table is provided to him. When the eligible person comes, the intervention group that is with A, B and C groups will be asked by phone or SMS, and the person will be placed in the desired group.
Blinding (investigator's opinion)
Single blinded
Blinding description
For the purpose of blinding, the placebo is made in the form of round tablets with a yellow coating similar to vitamin C tablets of Amin Pharmaceutical Company and poured into similar glass containers, and each batch is coded. They don't know about received and done coding.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Dentistry-Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1401.056

Health conditions studied

1

Description of health condition studied
The repair of extracted tooth socket
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Socket depth
Timepoint
Immediately after extraction, 7 days and 21 days after tooth extraction
Method of measurement
From the marginal gingiva to the point where the probe enters the socket in mm

2

Description
Mesiodistal dimension
Timepoint
Immediately after extraction, 7 days and 21 days after tooth extraction
Method of measurement
Measurement of the mesiodistal dimension of the silent tooth at the CEJ level of the adjacent teeth in millimeters

3

Description
Buccolingual dimension
Timepoint
Immediately after extraction, 7 days and 21 days after tooth extraction
Method of measurement
Measurement of the buccolingual dimension of the silent tooth at the CEJ level of the adjacent teeth in millimeters

4

Description
Pharmaceutical group
Timepoint
At the beginning of the study
Method of measurement
local/systemic

5

Description
Age
Timepoint
At the beginning of the study
Method of measurement
The number of years in a person's life

6

Description
Sex
Timepoint
At the beginning of the study
Method of measurement
A person's physical phenotype

Secondary outcomes

empty

Intervention groups

1

Description
Control group: placebo receiver
Category
Placebo

2

Description
First intervention group: Topical vitamin C receiver
Category
Treatment - Drugs

3

Description
Second intervention group: Systemic vitamin C recipient
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Faculty of Dentistry
Full name of responsible person
seyed mohammad arab farashahi
Street address
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
sma.farashahi_69@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyed mohammad arab farashahi
Street address
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
sma.farashahi_69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
seyed mohammad arab farashahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
sma.farashahi_69@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyed mohammad arab farashahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
sma.farashahi_69@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyed mohammad arab farashahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
sma.farashahi_69@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
From September 2021 to 1 year after the publication of the article
To whom data/document is available
For all people, including those working in academic and scientific institutions and industry
Under which criteria data/document could be used
Email and call
From where data/document is obtainable
mohammad arab farashahi, 09133735190, sma.farashahi_69@yahoo.com
What processes are involved for a request to access data/document
After sending the email, the data is transferred
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