Protocol summary

Summary
This study aims to determine the effects of Anaheal Bromelain on the clinical parameters of periodontal diseases in non-surgical treatment for the patients with moderate chronic periodontitis. The study was implemented as a double-blind, placebo-controlled, single center, phase-one trial. So that, a number of 80 patients aged 15 to 60 years old were admitted to the study with the following inclusion criteria: patients who suffer from moderate chronic periodontitis with clinical attachment loss (CAL) of 3 to 4 millimeters who were systemically healthy. Exclusion criteria for this study were as follows: Sensitivity to the medication (patients with sensitivity to pineapple, celery, carrot and fennel may also have sensitivity to Bromelain),History of cardiac diseases, Pregnant women, Gastrointestinal diseases such as peptic ulcer ,Renal or Hepatic Diseases, Coagulate anomalies such as hemophilia, Systemic lupus erythematous, Any history of periodontal treatment (scaling, root planning or surgery) at the past six months, Alcohol, cigarette or drug consumption, Concurrent Anti-coagulant or thrombolytic therapy. In the present study, patients were randomly divided into two groups of 40. Anaheal Bromelain was prescribed to one of the groups and the patients of the other group received a placebo. After charting, mouth hygiene instructions, scaling treatment and root planning carried out and indexes of clinical attachment loss (CAL), blood on probing (BOP), plaque index (PI) , plaque depth (PD)and gingival index(GI) were evaluated and recorded. Furthermore, the medication and placebo prescription after four and eight weeks, and synchronic non-surgical treatment and clinical parameters measurement were performed for patients and any improvement in clinical parameters was recorded according to the comparison between the values before and after the standard treatment and supplementary Anaheal Bromelain reception. BOP, CAL, PD and GI were measured by periodontal probe and plaque index was measured by disclosing tablets.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051114440N3
Registration date: 2017-07-08, 1396/04/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Alli Zarandi
Name of organization / entity
Dental Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5921
Email address
zarandia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of anahealbormelain on clinical parameters of periodontal in non-surgical paients with chronic periodontitis
Public title
Effect of anahealbormelain on clinical parameters of periodontal in non-surgical paients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who suffer from moderate chronic periodontitis with clinical attachment loss (CAL) of 3 to 4 millimeters who were systemically healthy. Exclusion criteria : Sensitivity to the medication (patients with sensitivity to pineapple, celery, carrot and fennel may also have sensitivity to Bromelain),History of cardiac diseases, Pregnant women, Gastrointestinal diseases such as peptic ulcer, Renal or Hepatic Diseases, coagulated anomalies such as hemophilia, Systemic lupus erythematous, Any history of periodontal treatment (scaling, root planning or surgery) at the past six months, Alcohol, cigarette or drug consumption, Concurrent Anti-coagulant or thrombolytic therapy
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Ethics
Street address
Street camping,Tabriz University of Medical Sciences,Vice Chancellor for research ofTabriz University of Medical Sciences,Tabriz University of Medical Ethics
City
Tabriz
Postal code
5166614713
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.TBZMED.REC.1396.61

Health conditions studied

1

Description of health condition studied
Patients with chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
CAL (clinical attachment level)
Timepoint
before the intervention, four weeks after initiating the intervention and eight weeks after initiating the intervention
Method of measurement
measurement of the distance between the stent margin to the sulcus base by means of a periodontal probe

Secondary outcomes

1

Description
Plaque
Timepoint
Before the intervention, four weeks after initiating the intervention and eight weeks after initiating the intervention
Method of measurement
by disclosing agent with visual scale

2

Description
Bleeding on probing(BOP)
Timepoint
before the intervention, four weeks after initiating the intervention and eight weeks after initiating the intervention
Method of measurement
bleeding in 15 seconds after gentle probing by periodontal probe

3

Description
Probing depth(PD)
Timepoint
Before the intervention, four weeks after initiating the intervention and eight weeks after initiating the intervention
Method of measurement
The distance between the mucosal margin and the sulcus base by periodontal probe in millimeters

4

Description
Gingival index(GI)
Timepoint
before the intervention, four weeks after initiating the intervention and eight weeks after initiating the intervention
Method of measurement
observation of index score

Intervention groups

1

Description
Intervention group: Scaling , root planning, Anaheal Bromelain prescription four times a day for eight weeks
Category
Treatment - Drugs

2

Description
Control group: Scaling ,root planning, placebo prescription four times a day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gum disease and Tooth Research Center,Vice Chancellor for Research of Dentistry Faculty of Tabriz
Full name of responsible person
Masoumeh Faramarzi and Shahriar Shahi
Street address
Dental Faculty of Tabriz University of Medical Sciences
City
Tabriz

2

Recruitment center
Name of recruitment center
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Street address
Department of Periodontics,Tabriz Dental Faculty ,Tabriz University of Medical Sciences
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Street address
Department of Periodontics,Tabriz Dental Faculty,Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontics,Tabriz Dental Faculty,Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 3334 6977
Fax
+98 41 1329 4312
Email
zarandia@tbzmed.ac ; dr.alizarandi@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontics,Tabriz Dental Faculty,Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 3334 6977
Fax
+98 13294312
Email
zarandia@tbzmed.ac ; dr.alizarandi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Aida Ataei
Position
Dental Student
Other areas of specialty/work
Street address
Department of Periodontics,Tabriz Dental Faculty,Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 3381 3399
Fax
Email
Aydaataei70@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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