1. Home
  2. Approved trials
  3. » فارسی

The Effectiveness Comparison of Aloe vera، Povidone Iodine and Chlorhexidine Mouthwashes in the Treatment of Patients with Gingivitis

Protocol summary

Study aim
Chlorhexidine Mouthwash is known as a Gold_standard treatment of gingivitis, however, many side effects from this Mouthwash have been reported. The aim of this study is to replace Chlorhexidine Mouthwash with Betadine or Aloe vera mouthwash.
Design
Clinical trial without Control Group, with three Parallel Groups, Double-Blind, Randomized, in each Person is controlled by the Same Person, Phase 2 on 27 Patients. SPSS Software was used for Randomization, in which Triple Blocks were randomly selected.
Settings and conduct
The blindness of a Researcher and a Statistical Consultant so that Mouthwashes are delivered with a Label through the Ward Secretary and the Consultant is not Aware of the Names of Mouthwashes in each Group. This Intervention is performed in the Periodontology Department of Kashan Dental School and after qualifying, the eligible Individuals will be evaluated for GI and SBI GBOB Indicators With the Help of a Periodontal Probe and Scaling will be performed for Patients. After A month of using Mouthwash, in the second session, Indicators are measured again. During this month, Patients' use of Mouthwashes will be monitored by Phone. Patients with good Cooperation are also re-evaluated 14 days after the intervention.
Participants/Inclusion and exclusion criteria
People with Gingivitis over 20 years without Bone Resorption؛ Absence of hyperthyroidism and allergies to Mouthwashes؛ Have not undergone Periodontal Treatment in the past six months.
Intervention groups
Group A is given Aloe vera Mouthwash, Group B Betadine, and Group C Chlorhexidine. All Patients will be given a medium Toothbrush and Floss along with Hygiene training
Main outcome variables
inflammation of the Gums will be evaluated, using the Gingival Index; Sulcular Bleeding Index, and Gingival Bleeding on Brushing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220409054462N1
Registration date: 2022-05-22, 1401/03/01
Registration timing: registered_while_recruiting

Last update: 2022-05-22, 1401/03/01
Update count: 0
Registration date
2022-05-22, 1401/03/01
Registrant information
Name
pouya Foghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3667 0458
Email address
pooya.foghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness Comparison of Aloe vera، Povidone Iodine and Chlorhexidine Mouthwashes in the Treatment of Patients with Gingivitis
Public title
The Effectiveness Comparison of Aloe vera، Povidone Iodine and Chlorhexidine Mouthwashes in the Treatment of Patients with inflamed Gums
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having at least 20 Teeth in the Mouth regardless of Third Molar Bleeding on Probing Having no Sensitivity to the Mouthwashes that exist in the intervention Absence of Periodontit Absence of Clinical Attachment loss Age over 20 years
Exclusion criteria:
Undergoing Periodontal Treatment in the past 6 months Systemic diseases such as Diabet، Radiotherapy، Cancer and Hyperthyroidism With Mental or Physical Retardation that could have influenced the Oral Hygiene Presence of Periodontal Pockets Pregnancy
Age
From 20 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 27
Randomization (investigator's opinion)
Randomized
Randomization description
The Subjects will be randomly divided into Three Groups receiving Chlorhexidine, Betadine and Aloevera. Thus, due to the Gradual Referral of Patients and to maintain the Balance of Individuals in Groups, Individuals are randomly selected by Permuted Block Randomization with Triple Blocks. Thus, based on Random Numbers obtained from SPSS Software, one of the Blocks with Sequence of ; CBA, CAB, BCA, BAC, ACB, ABC is selected. The letter A means the Person assigned to the Aloevera Group, the letter B means the Person assigned to the Betadine Group, and the letter C means the Person assigned to the Chlorhexidine Group. The Mouthwashes are delivered to Patients in Black Bottles with Labels of A, B, and C.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Therapist delivers the Triple Blocks provided by the Software to the Ward Secretary, and the Mouthwashes are delivered to the Patients along with the Label, following the Blocks, by the Secretary to the Patients. The Statistical Consultant does not know the Names of Mouthwashes in Groups A, B, and C.
Placebo
Not used
Assignment
Parallel
Other design features
Photographs are also taken of patients before and after the intervention, which can help assess how the Gums are healing. It should be noted that Individuals are evaluated to enter the study through Periodontal Risk Assessment software and Individuals with Medium risk and higher are involved in the intervention. both Jaws are examined separately for Indicators.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
No. 25, West Shahid Amini Nezhad Ave or West Haft dast Ave.,Chahar Bagh Bala Ave., Esfahan City
City
Esfahan
Province
Isfehan
Postal code
8163614520
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.175

Health conditions studied

1

Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
Determination and Comparison of total and mean Gingival Index score in three Groups receiving Mouthwashes (Aloe vera, Betadine and Chlorhexidine) before and after Treatment.
Timepoint
A month after the intervention
Method of measurement
To measure the Gingival Index by looking at the Gingival soft tissue, a score of zero to three is given to each of the four areas of the Gingival Soft Tissue of each Tooth. The Scores from the four areas of the Tooth are added together and divided by four to obtain a Specific Gingival Index for each Tooth. The average of Gingival Index is obtained by dividing the Total Gingival Index Score of all Teeth by the Number of Teeth. Each score should have several specific characteristics that are different from the other Score so that the Therapist can easily Determine the score. Zero Grade means Normal Gingival Tissue: Pink or Pale Pink, varying degrees of Stippling, Placement of the Gingival margin on the Enamel or at different levels more apical than Cemento Enamel Junction, firm Gingival Tissue when touched by the Periodontal Probe Grade 1 means Mild Inflammation: Mild Discoloration, slightly reddish Gingival margin, slight Swelling, accumulation of colorless Exudate in the Gingival Margin, no Bleeding during Probing Grade 2 means Moderate inflammation: Red or Blue-red Gingival Tissue Color Glossy, increased Gingival margin due to swelling, Bleeding during Probing grade 3 means Severe inflammation: Marked redness and swelling, Sores, tendency to Bleed spontaneously Examination of all Tooth Surfaces for the Gingival Index begins with the upper right Second Molars and continues to the Midline and upper left Second Molars. The order of Examination on the right starts from the Distal and then the Buccal and Mesial are evaluated. The order of Examination on the left starts from the Mesial and then the Buccal and Distal are examined. After examining all three Mesial, Buccal, and Distal Surfaces, evaluation of the Palatal Surface of the Maxillary Teeth starts from the left second Molar. Examination of the Mandible begins at the left second Molar and continues toward the right Second Molar. The order of Examination on the left is first Distal, then Buccal and Mesial, and on the right is first Mesial, then Buccal and Distal, and finally the lingual Surface is evaluated from the Second left Molar. Mild Inflammation Scores range from 0.1 to 1; Moderate Inflammation is from 1.1 to 2 and severe Inflammation is from 2.1 to 3

2

Description
Determining and Comparing Sulcular Bleeding Index score in three Groups receiving Mouthwashes (Aloe vera, Betadine and Chlorhexidine) before and after Treatment
Timepoint
A Month after the intervention
Method of measurement
Factors such as Marginal Gingival and papillary swelling with or without Ulceration, Marginal Gingival and Papillary Discoloration, and Bleeding during Probing are important in determining the Sulcular Bleeding Index score, so that a score of 0 indicates papillae and a Healthy marginal gingiva score of 1 indicates Bleeding during Probing, without Discoloration and swelling of Papillae and Marginal Gums score 2 indicates Discoloration and Bleeding during probing, without Gingival swelling score 3 related to Discoloration and Bleeding during probing and slight swelling of the Gums A score of 4 indicates Discoloration and Bleeding during probing and marked swelling of the Gums. A score of 5 indicates Discoloration and Spontaneous Bleeding during probing, a marked swelling that may or may not have Ulcer In the study of Sulcular Bleeding Index, each Jaw is examined separately and is divided into three Sextants. In each Sequence, the Buccal and Lingual Gums are examined separately, and each one that received a higher score is considered as the main score of the Sequence and is compared to the main score of the other two Sextants obtained in the same way. In each Jaw, any Sequence that has a higher score will be compared to subsequent Sessions to evaluate the quality of the intervention.

3

Description
Comparison of Bleeding Differences when brushing (Gingival Bleeding on Brushing) in three Groups receiving Mouthwashes (Aloe vera, Betadine and Chlorhexidine), before and after Treatment
Timepoint
A Month after the intervention
Method of measurement
This Indicator is an important Sign for the Presence or Absence of Gingivitis or Periodontitis, and realizing it can increase People's self-awareness about Gum Health and effective and timely Solutions can be adopted for Treatment. This Index is higher in Gingivitis Patients and is associated with inflammatory lesions. In this Study, People are asked about bleeding when brushing before scaling, and the same Question is repeated after the Intervention. If the Patient states in the first Session that there is no bleeding while brushing, the Evaluation will depend on the Sulcular Bleeding Index and Gingival Index.

Secondary outcomes

1

Description
Evaluation and Comparison of Mouthwash Solutions in terms of Complications (Tooth Discoloration, bad Breathing and Irritation) after the intervention.
Timepoint
A month after intervention
Method of measurement
Patients are asked about the feeling of Change in the Taste and Smell of the Mouth or Burning after using Mouthwashes. Also, using Photographs and asking patients, the amount of discoloration of the Teeth is assessed because in the First Session scaling is done for all Patients. And Discoloration of the Teeth after a Month can indicate the Effect of Mouthwashes.

Intervention groups

1

Description
First intervention group: Aloe vera Mouthwash was assigned to this Group. In this study, 120 ml of Aloe vera Mouthwash Syrup produced by the Company of Barij Esans Kashan is used. which contains 2.5 mg of Glaucoma (Sugar of Konjac Plant) in every 5 ml of Syrup and with a concentration of 50%, the rest is composed of Honey. Patients rinse 10 ccs of this Mouthwash once a Day, before going to bed, for one Month, and then pour it out.
Category
Treatment - Drugs

2

Description
Second intervention group: Betadine Mouthwash was assigned to this Group. It is a Solution of Iodine and Polyvinyl Pyrrolidone in Molecular form. A solution of 250 ml of 10% Betadine produced by Behsa Company is used for this purpose. It is then diluted with a graduated Cylinder in a ratio of 9 Water to 1 Betadine to achieve the desired concentration of 1%. Patients rinse 10 ccs of this Mouthwash once a Day, before going to bed, for one Month and then pour it out.
Category
Treatment - Drugs

3

Description
Third Intervention group: Chlorhexidine Mouthwash assigned to this Group is a Cationic Bisbiguanide with a wide range of functions. In this study, a 250 ml Solution produced by Behsa Company with a Concentration of 0.2% is used. To achieve a Dose of 20 mg, Patients are asked to rinse their Mouths with 10 ml of 0.2% Chlorhexidine Mouthwash for 30 seconds for one Month and every Night before Bed and then pour it out.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Dental School
Full name of responsible person
Sara Ebrahimi
Street address
3 km of Qotb Ravandi Ave, Pezeshk Blvd.,Kashan City
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3667 0458
Email
pooya.foghi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sara Ebrahimi
Street address
Third Kilometer of Qotb Ravandi Ave., Pezeshk Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3667 0458
Email
sara_ebrahimi64@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan University of Science
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
Kashan University of Medical Sciences
Full name of responsible person
Sara Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Third Kilimeter of Qotb Ravandi Ave., Pezeshk Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
0098 21 555431
Email
sara_ebrahimi64@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sara Ebrahimi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Third Kilometer of Qotb Ravandi Ave., Pezeshk Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
0098 21555431
Email
sara_ebrahimi64@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Pouya Foghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 25, West Haft Dast or Shahid Amini Nezhad Ave., Chahar Bagh Bala Ave., Esfahan City
City
Esfahan
Province
Isfehan
Postal code
8163614520
Phone
+98 31 3667 0458
Email
pooya.foghi@yahoo.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
Loading...