Protocol summary

Study aim
Determining the average control time of alveolar Socket bleeding after using gauze impregnated with 20% and 40% extract of Mespilus germanica L. and gauze impregnated with normal saline.
Design
Clinical trial with first intervention group (20% extract), second intervention group (40% extract), and control group (normal saline) with parallel groups, Three blind strains, Randomized, Phase 3 trial on 90 patients, Random allocation2 software was used for randomization.
Settings and conduct
In the department of surgery of Mazandaran university of medical sciences, sterilized gauzes in wet thermal autoclave with 4 cc extracts of 40 % and 20 % and normal saline are impregnated and then dried the gauzes in oven. the tooth is extracted by simple extraction method. The gauze is put into the patient's mouth with mild contact and soaked with normal saline. Every 5 minutes the gauze is removed from the patient's mouth and the bleeding or discontinuation is recorded. Due to the color matching of the solutions, the evaluator, patient, and statistical consultant participate in blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mandibular Molars Extraction and Age ≥ 18 years, Insensitivity to the extract, Patients with ASA I and II, No smoking and hookah, Amenorrhea during surgery, Not using contraceptives, Not having a clotting disorder, Absence of uncontrolled infection at the surgical site Exclusion criteria: The presence of a large periapical lesion, the complications during surgery such as flap rupture, Patients with moderate and severe periodontal disease
Intervention groups
Gauze impregnated with 20% extract of Mespilus germanica L. (A - treatment group) Gauze impregnated with 40% extract of Mespilus germanica L. (B - treatment group) Gauze impregnated with normal saline (C - control group)
Main outcome variables
Bleeding rate (clot formation) Bleeding control time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240928063195N1
Registration date: 2024-12-09, 1403/09/19
Registration timing: prospective

Last update: 2024-12-09, 1403/09/19
Update count: 0
Registration date
2024-12-09, 1403/09/19
Registrant information
Name
Mahsa Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3323 7198
Email address
zaremahsa12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-03, 1404/01/14
Expected recruitment end date
2025-06-08, 1404/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Hydroalcoholic Extract of Mespilus germanica L. Fruit on the Control of Alveolar Socket Bleeding after Mandibular Molars Extraction
Public title
Evaluation of the Effect of Mespilus germanica L. Fruit Extract on the Control of Alveolar Socket Bleeding after Mandibular Molars Extraction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular Molars Extraction Age ≥ 18 years Insensitivity to Mespilus germanica L. Fruit extract Not using complementary medical methods (herbal drugs, etc.) in the last month Not having a clotting disorder Absence of acute or uncontrolled infection at the surgical site Patients with ASA I and II and absence of any uncontrolled medical problem Not using contraceptives in the last month Not using any medication that interferes with bone repair and blood coagulation No smoking and hookah Amenorrhea during surgery
Exclusion criteria:
Patients with a large periapical lesion Patients with complications during surgery such as flap rupture Patients with moderate and severe periodontal disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
People who met the entry criteria were placed in two treatment groups and one control group. sterile gauzes soaked with extract of 20 % and 40 % Mespilus germanica L. were used for treatment group and sterile gauzes soaked with normal saline were used for control group. random block method will be used to allocate samples to three groups. For this purpose, patients will receive the number 1 to 90 according to the selection order. The randomization unit will be individually and by number with blocks of three people. The selection of the group type for each person will be done through random allocation2 statistical software. In order to construct a random sequence, codes A, B and C will be generated from the software, where code A means applying the the first intervention group (20% extract) and code B means applying the second intervention group (40% extract) and Code C means applying the control group to each person. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Due to the homogenization of the color of the normal saline solution and the extracts with each other, the evaluator, the patient and the statistical consultant are involved in blinding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
No.9, 9th Keshavarz Alley, Keshavarz Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4813797981
Approval date
2024-07-09, 1403/04/19
Ethics committee reference number
IR.MAZUMS.REC.1403.189

Health conditions studied

1

Description of health condition studied
Control of Alveolar Socket Bleeding after Mandibular Molars Extraction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of people who have faster bleeding control with gauze impregnated with Mespilus germanica L. extract
Timepoint
Measuring the clot formation time every 5 minutes after starting to place the gauze on the socket of the extracted tooth
Method of measurement
Every 5 minutes, the formation or non-formation of a clot in the socket of the extracted tooth is confirmed by the maxillofacial surgeon.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: gauze impregnated with a 20% extract of Mespilus germanica L. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in 20% Mespilus germanica L. extract is given to the maxillofacial surgeon by the student and used for the first treatment group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon.
Category
Prevention

2

Description
The second intervention group: gauze impregnated with a 40% extract of Mespilus germanica L. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in 40% Mespilus germanica L. extract is given to the maxillofacial surgeon by the student and used for the first treatment group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon.
Category
Prevention

3

Description
Control group: gauze impregnated with normal saline. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in normal saline is given to the maxillofacial surgeon by the student and used for control group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Surgery, Faculty of Dentistry, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Amirhossein Moaddabi
Street address
Baghban Dental Clinic, Khazar Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3323 7198
Email
zaremahsa12@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
No.9 , Haghighat Alley, 9th Keshavarz Alley , Keshavarz Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4813797981
Phone
+98 11 3323 7198
Email
zaremahsa12@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mahsa Zare
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Haqiqat Alley, The Ninth Keshavarz, Keshavarz Blvd, Sari town, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4813797981
Phone
+98 11 3323 7198
Fax
Email
zaremahsa12@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr AmirHossein Moaddabi
Position
Associate professor of oral and maxillofacial surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
ghu Building, Gharan Street , Sari Town
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
a.moaddabi2@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahsa Zare
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Haqiqat Alley, The Ninth Keshavarz, Keshavarz Blvd, Sari town, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4813797981
Phone
+98 11 3323 7198
Fax
Email
zaremahsa12@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
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
Undecided - It is not yet known if there will be 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
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