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CTRI Number  CTRI/2024/04/065282 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Clarithromycin Gel and Chlorhexidine Gel after full mouth cleaning in pyorrhea patients.  
Scientific Title of Study   Comparative evaluation of Clarithromycin Gel and Chlorhexidine Gel as local drug delivery agents as an adjunct to scaling and root planing in the management of patients with chronic periodontitis (stageIII gradeB)-A clinico-microbiological study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aishwarya Sawai 
Designation  Postgraduate student 
Affiliation  Dr HSRSM Dental College And Hospital 
Address  Department of Periodontology Room no 15 2nd floor Dr. HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli

Hingoli
MAHARASHTRA
431513
India 
Phone  7744036690  
Fax    
Email  sawaiaishwarya52@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monica Mahajani 
Designation  Professor and Head of Department 
Affiliation  Dr HSRSM Dental College And Hospital 
Address  Department of Periodontology Room no 15 Dr. HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli

Hingoli
MAHARASHTRA
431513
India 
Phone  9322855839  
Fax    
Email  mahajanimonica@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aishwarya Sawai 
Designation  Postgraduate student 
Affiliation  Dr HSRSM Dental College And Hospital 
Address  Department of Periodontology Room no 15 2nd floor Dr. HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli

Hingoli
MAHARASHTRA
431513
India 
Phone  7744036690  
Fax    
Email  sawaiaishwarya52@gmail.com  
 
Source of Monetary or Material Support  
Dr. HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli 
 
Primary Sponsor  
Name  Dr Aishwarya Sawai 
Address  Dr. HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monica Mahajani  Dr. HSRSM Dental College and Hospital  Department of Periodontology Room no 15 2nd floor Dr. HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli
Hingoli
MAHARASHTRA 		 9322855839

mahajanimonica@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr HSRSM Dental College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, (2) ICD-10 Condition: Z77-Z99||Persons with potential health hazards related to family and personal history and certain conditions influencing health status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine gel  Chlorhexidine Gel as local drug delivery agents as an adjunct to scaling and root planing in the management of patients with chronic periodontitis stageIII gradeB at 3 months 
Comparator Agent  Clarithromycin gel  Clarithromycin Gel as local drug delivery agents as an adjunct to scaling and root planing in the management of patients with chronic periodontitis stageIII gradeB at baseline 6 weeks and 3 months 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A minimum of 20 teeth should be presented in the mouth of the patients
Generalized Chronic Periodontitis StageIII GradeB patient with at least 2 non-adjacent teeth in 2 contralateral quadrants with a Clinical attachment level of more than 3mm and Probing pocket depth of 4-6mm
Patients with no history of allergies 
 
ExclusionCriteria 
Details  Patients suffering from any known systemic diseases
Smokers and alcoholic patients
Medication taken by the patient that would induce gingival enlargement
Pregnancy or lactating female patients
Patients who have received surgical or nonsurgical periodontal therapy in the last 3 months before the baseline visit
Patients who received systemic antimicrobial therapy in the last 2 months before entry
Patients who have received clarithromycin and chlorhexidine gel in the past
Patients who have received any antibiotics chemotherapeutic mouth rinse or oral irrigation during the past 3 months
Patients allergic to any medication 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in microbial parameters using conventional PCR technique  At baseline and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in clinical parameters
Plaque index (PI)
Gingival index (GI)
Modified sulcular bleeding index (mSBI)
Probing pocket depth (PPD)
Clinical attachment levels(CAL)  		 At baseline 6 weeks and 3 months 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE:-

Comparative evaluation of Clarithromycin Gel and Chlorhexidine Gel as local drug delivery agent as an adjunct to scaling and root planing in the management of patients with chronic periodontitis (stageIII gradeB)– A clinico-microbiological study.

INTRODUCTION:-

The term "periodontitis" originates from two words, i.e., "periodont-" meaning "structure surrounding the teeth" and "itis" means "inflammation."

Chronic periodontitis is defined as an inflammatory disease of tooth‑supporting tissues and if not treated, can lead to progressive attachment loss causing destruction of the tissues, which is clinically characterized by gingival bleeding, progressively increasing pocket depth, clinical attachment loss and alveolar bone loss, which eventually results in teeth loss. The prevalent etiology for periodontal diseases is the complex of dysbiotic microbiota present in dental plaque biofilm.

600 different species of bacteria are present and colonize in the oral cavity which alter the balance of host-bacterial interactions ultimately leading to periodontal disease.

Gram-negative anaerobic bacteria, such as Porphyromonas gingivalis (P.gingivalis), A. actinomycetemcomitans, Prevotella intermedia, Tannerella forsythia, Treponema denticola Streptococcus oralis, Streptococcus intermedius, Peptostreptococcus micros, and Fusobacterium nucleatum are dominant flora associated with chronic periodontitis. Among all these microorganisms Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia forms the Red complex which are considered to be associated with chronic periodontitis. In chronic periodontitis 85% of diseased site is mostly associated with P.gingivalis. The disease progression in periodontal pocket may be predicted by the increase of P.gingivalis. Hence reduction in count of P.gingivalis is analogous with resolution of disease at affected site.

Scaling and root planing (SRP) is still the benchmark for nonsurgical treatment of chronic periodontitis, but it has certain limitations such as incomplete removal of calculus from the posterior teeth or teeth having pocket depth 3mm. To overcome these problem surgical therapy was developed but long term therapy did not show any superior results in term of periodontal attachment gain. Thus antimicrobials came into existence which have proven beneficial after non-surgical and surgical therapy.

Antimicrobials are available in various local drug delivery (LDD) forms such as Chlorhexidine (CHX), Clarithromycin (CLM), Tetracyclines, Metronidazole, Azithromycin, Moxifloxacin, Simvastatin, Metformin and Alendronate which are presently being used in various drug delivery systems such as irrigations, fibers, films, injectable, gels, strips, compacts, vesicular liposomes, microparticles, and nanoparticle systems in the management of periodontal disease.

Over other preparations gel formulations have more advantages. Gels can be more easily prepared and administered. They also have properties of higher biocompatibility and more bioadhesive allowing easy adhesion into the periodontal pocket, sustained drug release pattern, minimum dose frequency, and drug toxicity.    

Clarithromycin and Azithromycin are macrolide antibiotics which are relatively new in terms of local application in the management of periodontal disease.

Macrolide antimicrobials are well endured and give a sound alternative for the treatment of odontogenic and periodontal infections. CLM is accumulated by phagocytes, monocytes, fibroblasts, polymorphonuclear cells, macrophages, and lymphocytes. One could expect greater benefits, as these cells are more prevalent at periodontal disease sites.

CLM has broad antimicrobial spectrum against Periodontal pathogens i.e P.gingivalis, better bioavailability, favorable tissue distribution, a low incidence of adverse drug reactions, high concentration in GCF and remains in GCF for long duration.

0.5% CLM gel when incorporated into subgingival periodontal pockets gives benefit till 6 months after application.

Chlorhexidine is the gold standard agent with which other antiplaque and antigingivitis agents are compared. The effectiveness of this agent depends on bactericidal and bacteriostatic effects and its substantivity in the oral cavity.

The introduction of LDD system in periodontal pocket gives promising clinical and microbiological outcomes and also enhances periodontal health when used as adjunct to nonsurgical periodontal therapy.

Hence the rationale of this study is to comparatively evaluate the clinical and microbiological effects of subgingivally delivered 0.5% Clarithromycin gel and 0.2% Chlorhexidine gel as an adjunct to SRP for treating Chronic periodontitis patients (stageIII gradeB).

AIM OF THE STUDY:-  The aim of the study is to evaluate the clinical & microbiological parameters using 0.5% Clarithromycin Gel and 0.2% Chlorhexidine Gel as a local drug delivery agent as an adjunct to scaling and root planing in the management of patients with  periodontitis (stageIII gradeB).


OBJECTIVE:-

Primary objective:-

To evaluate and compare the effects of 0.5% Clarithromycin gel and 0.2% Chlorhexidine gel used as an adjunct to SRP in the treatment of subjects with periodontitis (stageIII gradeB) as seen by change in clinical parameters at baseline, 6 weeks, and 3months and change in microbial parameter at baseline and 6 weeks respectively.

OTHER OBJECTIVE 1:-

1)To evaluate the effect of 0.5% Clarithromycin gel with SRP on clinical periodontal parameters at baseline, 6 weeks & 3months & microbiologic parameters at baseline, 6weeks respectively in patients of periodontitis (stageIII gradeB).

2)To evaluate the effect of 0.2% Chlorhexidine gel with SRP on clinical periodontal parameters at baseline, 6 weeks & 3months & microbiologic parameters at baseline, 6weeks respectively in patients of periodontitis (stageIII gradeB).

OTHER OBJECTIVE 2:-

To find out the best effect among LDD agent 0.5% Clarithromycin gel & 0.2% Chlorhexidine gel  when used  as an adjunct to scaling and root planing in the treatment of the subjects with periodontitis(stageIII gradeB) as evaluated by change in clinical parameters of PI, GI, mSBI, PPD, CAL at baseline, 6 weeks, and 3months and change in microbial parameter including bacterial load of P.gingivalis at baseline and 6 weeks respectively.

METHODOLOGY:-

STUDY DESIGN:-

This is a randomized clinical and microbiological split mouth study.

STUDY SETTING:-

The study would be conducted abiding by all human ethical principles as per the WMA- Declaration of Helsinki and the Guidelines of Good Clinical Practice (ICMR) will be observed. The study will be performed with each subject unaware of which intervention each study tooth is being subjected to. Measurements of the evaluation parameters will be performed by a nonblinded single trained operator. The statistician shall however be blinded to the intervention groups.

STUDY POPULATION:-

The study will be performed on systemically healthy volunteer subjects screened for inclusion criteria by simple random sampling from their presentation for examination at the Dental college after fulfilling the inclusion criteria and rendering informed consent through signed document in English and local language to participate in the study over a study period of 3 months from baseline.

Sample size:-  

·       The calculated sample size is 26 patients (52sites).

      Sampling technique:

·       The study will be conducted in patients having periodontitis (stageIII gradeB).

·       An informed consent will be taken in local and English language.

·       The test and control group are as follows-

Control group – Patient undergoing SRP + 0.2% chlorhexidine gel

Test group  â€“ Patient undergoing SRP + 0.5% clarithromycin gel  

Inclusion criteria:

·       Both male and female patients with generalized chronic periodontitis (stageIII gradeB).

·       Age group between 35-60 years with good systemic health.

·       Minimum 20 teeth should be present in the mouth of patients.

     Periodontitis patient with atleast 2 non-adjacent teeth in 2 contralateral quadrants with CAL > 3mm and PPD 4-6mm.

     Patients with no history of allergies.

    Exclusion criteria:

·       Patients suffering from any known systemic diseases.

·       Smokers and alcoholic patients.

·       Medication taken by patient that would induce gingival enlargement.

·       Pregnancy or lactating female patients.

·       Patients who have received surgical or nonsurgical periodontal therapy in last 3 months prior to the baseline visit.

·       Patients who received systemic antimicrobial therapy in last 2 months prior to entry.

·       Patients who have received clarithromycin and chlorhexidine gel in the past.

·       Patients who have received any antibiotics, chemotherapeutic mouth rinse or oral irrigation during past 3 months.

·       Patients allergic to any medication.

     EVALUATION PARAMETERS

I) Plaque index (PI) (Silness and Loe, 1964)
II) Gingival Index (GI) (Loe and Silness, 1963)
III) Modified Sulcus bleeding index (mSBI) (Mombelli, M.A.Van Oosten, E.Schurch.Jr & N.P.Land 1987
IV) PROBING POCKET DEPTH(PPD)
V) Clinical attachment level(CAL)
VI) Microbiological analysis:-

Microbiological analysis will be done at baseline and at 6weeks.

Tris-EDTA buffer (TE buffer) has been provided as transport media in sterile vials.

The vials containing transport media can be stored in refrigerator (4ºC) for around one month. The vials are discarded if TE buffer gets turbid.

Visible amount of plaque sample is collected from both test and control site at baseline and 6weeks using Universal curettes (2R-2L, 4R-4L).

 Plaque sample is then immediately transferred to the TE buffer vials and lid is closed.

 The collected samples can store in a refrigerator (4ºC) for maximum 2 days before sending the vials to laboratory.

PROCEDURE:-

·       This will be a split mouth design study.

·       The patients will be subjected to careful oral examination under proper illumination.

·       A brief case history will be recorded from all 26 patients

·       An informed consent will be taken from each of them.

·       A total number of 13 patients with 26 sites each will be randomized into 2 treatment groups (13 sites in each group). In test group, sites will be treated with SRP followed by placement of prepared 0.5% CLM agent and in the control group site will be treated with SRP followed by placement of 0.2% CHX.

     Periodontal status will be assessed at baseline preoperatively and at 6weeks and 3 months postoperatively by using Plaque Index (Silness & Loe 1964), Gingival Index (Loe & Silness 1963) Modified Sulcus Bleeding Index. Probing pocket depth and clinical attachment level will be measured by acrylic stent using a color-coded periodontal probe (UNC 15 color-coded periodontal probe; Hu-Friedy, Chicago,).

·    For microbiological analysis plaque samples will be collected from test and control site in contralateral quadrant and transferred into Tris-EDTA buffer (transport media vials).

·     At baseline after clinical and microbiological parameters are assessed, patient will undergo SRP until the root surface is considered smooth and clean by the operator. After completion of SRP, prepared local drug delivery agents (0.5% CLM gel and 0.2% CHX gel) will be placed in the periodontal pocket of each quadrants in the patients. This placement will be done by 24 gauge angulated blunt cannula syringe until it will be detected at the gingival margin.

·       In each patient only one site in one quadrant will be enrolled for either the CLM or CHX. Patients will be masked for allocation into the CLM or CHX groups.

·       To ensure retention of the gel to be effective in the pocket, a periodontal dressing (CoePak) will be given for seven days.

·       No antibiotics or anti-inflammatory agents will be prescribed after treatment.

·       Postoperative home care brushing instructions will be given.

 
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