GingivitisNCT03839719
OSE as a Pre-procedural Mouth Rinse: A Clinical and Microbiological Study.
A study testing Group PI, Group OC and Group CHX in people with Gingivitis and Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.
Trial summary
Periodontal disease- Inflammatory, Multifactorial, and Threshold disease. Periodontal disease is a highly prevalent dental disease, an almost 100% prevalence in developing countries. Non-surgical periodontal includes scaling and root planing (SRP) an essential part of successful periodontal therapy. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis, Aerosol Disease
- What is being tested?
- Group PI, Group OC and Group CHX
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 9 Jan 2019to 25 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cases with Generalized Chronic Gingivitis or cases with mild
- Generalized Chronic Periodontitis patients of any sex.
- Systemically healthy individuals.
- Patient having ≥ 20 teeth.
- Patients in the age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent.
Who cannot join
- Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
- Patients on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
- Patients who have known allergy to the material used for the study.
- Pregnant and lactating mothers.
- Patients had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, in the past 6 months.
- Tobacco users (smoke and smokeless) and alcoholics.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of periodontology, GDC Indore
Indore, Madhu Pradesh, 452001
About this study
Official title: Efficacy of Ocimum Sanctum as a Pre-procedural Mouth Rinse in Reducing Aerosol Contamination Produced by Ultrasonic Scaler: a Clinical and Microbiological Study.
- Periodontal disease- Inflammatory, Multifactorial, and Threshold disease. Periodontal disease is a highly prevalent dental disease, an almost 100% prevalence in developing countries.
- Non-surgical periodontal includes scaling and root planing (SRP) an essential part of successful periodontal therapy.
- The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on The Health of patients and Dental Health care Professionals.
- Aerosols are generated during Tooth preparation/Rotary instrument/ air abrasion/Air-water syringe, Ultrasonic scaler, and while doing Air polishing.
- Studies have also reported an association of these aerosols with Respiratory infections, Ophthalmic and Skin infections, Tuberculosis, and Hepatitis B. current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.
- Chlorhexidine mouthwash is regarded as Gold Standard mouthwash but, have many local side effects including have many local side effects including extrinsic tooth and tongue brown staining, taste disturbance, enhanced supragingival calculus formation, less commonly, desquamation of oral mucosa, and even liver damage in rats.
- In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method.
- Ocimum Sanctum (Tulsi) is known as THE QUEEN OF HERBS effective in reducing plaque accumulation, gingival inflammation, and bleeding \& has no side effects as compared to Chlorhexidine. Very few studies which can be counted on fingers have been conducted worldwide in this direction, globally showing their beneficial effects.
Read the detailed description
The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on the health of patients and dental health care professionals. Aerosol and splatter are a concern in dentistry because of their potential effects on the health of immuno-compromised patients and of dental personnel. These aerosols may be inhaled into the lungs to reach the alveoli or may come in contact with the skin or mucous membranes. Most of the aerosols produced during treatment procedures have a diameter of 5μm or less, and these can cause respiratory or other health problems because they can penetrate into, and remain within the lungs. The oral cavity consists of billions and billions of microorganisms, which can get transmitted from one person to another through water contamination, surface contact or through aerosols. Aerosols are generated during tooth preparation with a rotary instrument or air abrasion, during the use of an air-water syringe, ultrasonic scaler, and while doing air polishing. Miller (1976) found that aerosols generated from patients' mouths contained up to a million bacteria per cubic foot of air.
All health care professionals including the dentists, dental hygienists, and nurses can get exposed to microorganisms present in patients' blood, saliva and from instruments, which can lead to cross infections. The oral cavity harbors numerous bacteria and viruses from the respiratory tract, dental plaque, and oral fluids. Viruses which are present in aerosols such as human immunodeficiency virus hepatitis B can penetrate the conjunctiva, respiratory tract of clinician, assistant, and patients. In addition to this, some viruses such as mumps, rubella, and influenza also pose a serious risk to health care professionals. Any dental procedure that has the potential to aerosolize saliva will cause contamination of air with organisms from some or all of these sources. Other studies have also reported an association of these aerosols with respiratory infections, ophthalmic and skin infections, tuberculosis, and hepatitis B. Current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.
Chlorhexidine gluconate, a bisbiguanide, is considered to be the gold standard of antimicrobial rinses because of broad-spectrum antibacterial activity but, it also has some side effects, notably tooth staining, taste alteration, enhanced supragingival calculus formation and less commonly desquamation of the oral mucosa. Also other then Chlorhexidine Providone iodine and essential oils are commonly used as mouthrinse.
In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method. Herbal medicine is both promotive and preventive in its approach. Also, herbal mouth rinses with their natural ingredients offer a safe and effective option as mouthrinse.
The herbal mouthwash used in this study is made from natural herb extracts of Ocimum sanctum. Ocimum sanctum is commonly known as 'Tulsi' and popularly known as 'The Queen of Herbs', and the "Mother Medicine of Nature" due to its perceived medicinal qualities. Tulsi extract has been widely used in traditional medicine and human clinical trial without significant side effects. Scientific investigations during the last several decades have shown that various parts of Ocimum sanctum, including leaves, stem, root, flowers, and seed, have a plethora of biological and pharmacological activities, including antioxidant, anti-inflammatory, antiallergic, immunomodulatory, antimicrobial etc.
Looking into the above background, The investigators hypothesized the beneficial effects of Pre-procedural rinsing with an antimicrobial mouthrinse in reducing the level of viable bacteria contained in aerosols generated by ultrasonic scaling. Also, very few studies are conducted on herbal products as a pre-procedural mouthrinse therefore, the study should be conducted to gain evidence regarding their effectiveness. So, The investigators have planned to conduct this study.
This study has been planned and would be conducted in the Department of Periodontology, Govt. College of Dentistry, Indore (M.P.). A minimum of 60 Recruited Outdoor Patients age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent are enrolled for the study.
- Being tested
- Group PI, Group OC, Group CHX
- Keywords
- Gingivitis, Aerosol, Ocimum sanctum, Mouth rinse, SRP, Chlorhexidine mouthrinse, Periodontitis
- Medical subject headings
- Gingivitis, Periodontitis, Gingival Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PIProcedure or surgery
Also called mouthrinse followed by Ultrasonic scaling
Before rinsing with the mouthrinse, Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity.
Group OCProcedure or surgery
Also called mouthrinse followed by Ultrasonic scaling
After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.
Group CHXProcedure or surgery
Also called Mouthrinse followed by Ultrasonic scaling
After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.
| Study group | Role | What they receive |
|---|---|---|
| Group OC | Experimental | Ocimum sanctum (OC) is a natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is also listed by the U.S. FDA as an herb Generally Recognized As Safe (GRAS) for its intended use as a therapeutic herb. Pharmacological constitutes present in the extract are eugenol, Urosolic acid, Carvacrol, linalool , limatrol, caryophyllene, and methyl carvicol. The literature showed that Ocimum sanctum extract has significant anti-gingivitis and anti-inflammatory effect as mouthrinse.
Other Names:
Tulsi Holy Basil Receives: Procedure: Group OC; Procedure: Group CHX |
| Group CHX | Active comparator | Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in a variety of oral disorders in various formulations.
As an antimicrobial agent, chlorhexidine is effective in vitro against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes and yeasts and fungi. The digluconate of chlorhexidine (1:6Di 4' chlorophenyl-diguani-dohexane) is a synthetic antimicrobial drug which has been widely used as a broad spectrum antiseptic.
Other Names:
Chlorhexidine Receives: Procedure: Group OC; Procedure: Group CHX |
| Group PI | Placebo comparator | Group PI: Placebo (Distilled water) as the mouthrinse.
Placebo (Distilled water) 10 ml is used as mouthrinse. Distilled water is commonly used as an excipient in a variety of drugs and it is also widely used as a placebo.
Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity.
Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria. Receives: Procedure: Group PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counting of the colony-forming units (CFU)
Preformed 10% blood agar plates were used which were incubated at 37°C for 48 hr after collecting the sample. Counting of the colony-forming units (CFU) was performed by the microbiologist, who was blinded regarding the time of exposure and location of agar plate. The microbial counting was done after that.
Measured: Up to 48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start9 Jan 2019
- Primary completion26 Apr 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient. Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria After ultrasonic scaling of the 1st and 4th quadrant and after 2nd and 3rd quadrant.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pratik kumar Ashok bhai Chaudhari, Government College of Dentistry, Indore
- Investigators
- DR.MADHU S. RATRE, M.D.S., Study director, Govt. college of dentistry, Indore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839719
- Sponsor's protocol ID
- 052/IEC/SS/2019
- Status last verified
- Jun 2019
- First submitted
- 1 Feb 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
PubMed 23855840Reddy S, Prasad MG, Kaul S, Satish K, Kakarala S, Bhowmik N. Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study. J Indian Soc Periodontol. 2012 Apr;16(2):213-7. doi: 10.4103/0972-124X.99264.
PubMed 23055587
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ocimum Sanctum as a Pre-procedural Mouth Rinse in Reducing Aerosol Contamination Produced by Ultrasonic Scaler: a Clinical and Microbiological Study.
- ClinicalTrials.gov ID
- NCT03839719
- Acronym / sponsor ID
- 052/IEC/SS/2019
- Keywords
- Gingivitis, Aerosol, Ocimum sanctum, Mouth rinse, SRP, Chlorhexidine mouthrinse, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Periodontal disease- Inflammatory, Multifactorial, and Threshold disease. Periodontal disease is a highly prevalent dental disease, an almost 100% prevalence in developing countries.
- Non-surgical periodontal includes scaling and root planing (SRP) an essential part of successful periodontal therapy.
- The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on The Health of patients and Dental Health care Professionals.
- Aerosols are generated during Tooth preparation/Rotary instrument/ air abrasion/Air-water syringe, Ultrasonic scaler, and while doing Air polishing.
- Studies have also reported an association of these aerosols with Respiratory infections, Ophthalmic and Skin infections, Tuberculosis, and Hepatitis B. current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.
- Chlorhexidine mouthwash is regarded as Gold Standard mouthwash but, have many local side effects including have many local side effects including extrinsic tooth and tongue brown staining, taste disturbance, enhanced supragingival calculus formation, less commonly, desquamation of oral mucosa, and even liver damage in rats.
- In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method.
- Ocimum Sanctum (Tulsi) is known as THE QUEEN OF HERBS effective in reducing plaque accumulation, gingival inflammation, and bleeding \& has no side effects as compared to Chlorhexidine. Very few studies which can be counted on fingers have been conducted worldwide in this direction, globally showing their beneficial effects.
Detailed description
The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on the health of patients and dental health care professionals. Aerosol and splatter are a concern in dentistry because of their potential effects on the health of immuno-compromised patients and of dental personnel. These aerosols may be inhaled into the lungs to reach the alveoli or may come in contact with the skin or mucous membranes. Most of the aerosols produced during treatment procedures have a diameter of 5μm or less, and these can cause respiratory or other health problems because they can penetrate into, and remain within the lungs. The oral cavity consists of billions and billions of microorganisms, which can get transmitted from one person to another through water contamination, surface contact or through aerosols. Aerosols are generated during tooth preparation with a rotary instrument or air abrasion, during the use of an air-water syringe, ultrasonic scaler, and while doing air polishing. Miller (1976) found that aerosols generated from patients' mouths contained up to a million bacteria per cubic foot of air.
All health care professionals including the dentists, dental hygienists, and nurses can get exposed to microorganisms present in patients' blood, saliva and from instruments, which can lead to cross infections. The oral cavity harbors numerous bacteria and viruses from the respiratory tract, dental plaque, and oral fluids. Viruses which are present in aerosols such as human immunodeficiency virus hepatitis B can penetrate the conjunctiva, respiratory tract of clinician, assistant, and patients. In addition to this, some viruses such as mumps, rubella, and influenza also pose a serious risk to health care professionals. Any dental procedure that has the potential to aerosolize saliva will cause contamination of air with organisms from some or all of these sources. Other studies have also reported an association of these aerosols with respiratory infections, ophthalmic and skin infections, tuberculosis, and hepatitis B. Current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.
Chlorhexidine gluconate, a bisbiguanide, is considered to be the gold standard of antimicrobial rinses because of broad-spectrum antibacterial activity but, it also has some side effects, notably tooth staining, taste alteration, enhanced supragingival calculus formation and less commonly desquamation of the oral mucosa. Also other then Chlorhexidine Providone iodine and essential oils are commonly used as mouthrinse.
In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method. Herbal medicine is both promotive and preventive in its approach. Also, herbal mouth rinses with their natural ingredients offer a safe and effective option as mouthrinse.
The herbal mouthwash used in this study is made from natural herb extracts of Ocimum sanctum. Ocimum sanctum is commonly known as 'Tulsi' and popularly known as 'The Queen of Herbs', and the "Mother Medicine of Nature" due to its perceived medicinal qualities. Tulsi extract has been widely used in traditional medicine and human clinical trial without significant side effects. Scientific investigations during the last several decades have shown that various parts of Ocimum sanctum, including leaves, stem, root, flowers, and seed, have a plethora of biological and pharmacological activities, including antioxidant, anti-inflammatory, antiallergic, immunomodulatory, antimicrobial etc.
Looking into the above background, The investigators hypothesized the beneficial effects of Pre-procedural rinsing with an antimicrobial mouthrinse in reducing the level of viable bacteria contained in aerosols generated by ultrasonic scaling. Also, very few studies are conducted on herbal products as a pre-procedural mouthrinse therefore, the study should be conducted to gain evidence regarding their effectiveness. So, The investigators have planned to conduct this study.
This study has been planned and would be conducted in the Department of Periodontology, Govt. College of Dentistry, Indore (M.P.). A minimum of 60 Recruited Outdoor Patients age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent are enrolled for the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient. Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria After ultrasonic scaling of the 1st and 4th quadrant and after 2nd and 3rd quadrant.
| Arm | Type | Receives |
|---|---|---|
| Group OC | Experimental | Procedure: Group OC, Procedure: Group CHXOcimum sanctum (OC) is a natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is also listed by the U.S. FDA as an herb Generally Recognized As Safe (GRAS) for its intended use as a therapeutic herb. Pharmacological constitutes present in the extract are eugenol, Urosolic acid, Carvacrol, linalool , limatrol, caryophyllene, and methyl carvicol. The literature showed that Ocimum sanctum extract has significant anti-gingivitis and anti-inflammatory effect as mouthrinse. Other Names: Tulsi Holy Basil |
| Group CHX | Active comparator | Procedure: Group OC, Procedure: Group CHXChlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in a variety of oral disorders in various formulations. As an antimicrobial agent, chlorhexidine is effective in vitro against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes and yeasts and fungi. The digluconate of chlorhexidine (1:6Di 4' chlorophenyl-diguani-dohexane) is a synthetic antimicrobial drug which has been widely used as a broad spectrum antiseptic. Other Names: Chlorhexidine |
| Group PI | Placebo comparator | Procedure: Group PIGroup PI: Placebo (Distilled water) as the mouthrinse. Placebo (Distilled water) 10 ml is used as mouthrinse. Distilled water is commonly used as an excipient in a variety of drugs and it is also widely used as a placebo. Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cases with Generalized Chronic Gingivitis or cases with mild
- Generalized Chronic Periodontitis patients of any sex.
- Systemically healthy individuals.
- Patient having ≥ 20 teeth.
- Patients in the age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent.
Key exclusion criteria (6 listed)
- Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
- Patients on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
- Patients who have known allergy to the material used for the study.
- Pregnant and lactating mothers.
- Patients had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group PIAlso: mouthrinse followed by Ultrasonic scalingBefore rinsing with the mouthrinse, Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. | Procedure or surgery | Group PI |
| Group OCAlso: mouthrinse followed by Ultrasonic scalingAfter ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient. | Procedure or surgery | Group CHX, Group OC |
| Group CHXAlso: Mouthrinse followed by Ultrasonic scalingAfter ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient. | Procedure or surgery | Group CHX, Group OC |
Primary outcome
Counting of the colony-forming units (CFU)
Time frame: Up to 48 hr
Preformed 10% blood agar plates were used which were incubated at 37°C for 48 hr after collecting the sample. Counting of the colony-forming units (CFU) was performed by the microbiologist, who was blinded regarding the time of exposure and location of agar plate. The microbial counting was done after that.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Results publication: PubMed 23855840Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
- Results publication: PubMed 23055587Reddy S, Prasad MG, Kaul S, Satish K, Kakarala S, Bhowmik N. Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study. J Indian Soc Periodontol. 2012 Apr;16(2):213-7. doi: 10.4103/0972-124X.99264.
- Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study.Link provided by the sponsor.
- Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR.MADHU S. RATRE, M.D.S. study director
Govt. college of dentistry, Indore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group PI, Group OC and Group CHX in people with Gingivitis and Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counting of the colony-forming units (CFU) (time frame: Up to 48 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.