Abstract: The present disclosure describes a novel method for reducing the harmful microbial load in 5 periodontal pockets by using a combination of low level laser therapy and Indocyanine Green as the photosensitizing dye. The method is effective in reducing the harmful microbial population in the periodontal pockets, without the use of antibiotics, and is used in improving the general oral hygiene and in prevention and non-surgical management of periodontitis.
FIELD OF THE INVENTION
Generally, the present disclosure relates to a method for improving oral hygiene. 5
BACKGROUND OF THE INVENTION
The current techniques known in the art to decrease the microbial load in the oral cavity involve either periodic mechanical disruption of oral microbial biofilms or maintaining therapeutic concentrations of antimicrobials in the oral cavity, both of which are fraught with limitations. 10
In upcoming years, problems arising from treatments with antibiotics will increase for the following reasons:
1. Increased resistance to antibiotics
2. Increase of immunosuppressed patients
3. Periodontal infections with various bacteria different from local pathogens, and the 15 consequent need for different and multiple antibiotics.
The possibility of development of resistance to antibiotics by the target organism has led to the development of a new antimicrobial concept with fewer complications.
Therefore, there is a need in the art for a method for management of oral hygiene without the use of antibiotics and more particularly an effective method for non-surgical management of 20 chronic periodontitis without the use of antibiotics.
SUMMARY OF THE INVENTION
A method for reducing the harmful microbial load in the periodontal pockets is provided, comprising the steps of:
a) Preparation of photosensitizing dye by dissolving Indocyanine Green powder in 25 Phosphate Buffered Saline (PBS) to obtain a solution of 250μg/ml concentration within 1 minute, wherein, the concentration of the Indocyanine Green dye is not more than 250μg/ml within 1 minute of its preparation;
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b) Application of the Indocyanine Green solution prepared in step (a) to the periodontal pockets of a person using a disposable 25gauge tuberculine syringe (with a side release cannula) loaded with the dye, by filling the periodontal pockets by running the tip of the needle in a apical to coronal direction to avoid entrapment of bubbles;
c) The Indocyanine Green dye applied in step (b) is made to stay in the periodontal 5 pockets for 10 minutes for complete uptake of the dye to take place;
d) Drying off of any extra dye solution applied to the periodontal pockets; and
e) Application of a 630nm diode laser on the periodontal pockets for illumination and activation of the dye in the pockets, wherein for application of the laser light, the laser tip is moved circumferentially in the test pockets around the tooth to target the following sites – 10 mesio facial; mid facial; disto facial and lingual/palatal aspects of single rooted teeth; and additional bifurcation and trifurcation areas in case of molars; and wherein the laser is applied in a continuous wave motion for 5 seconds/site, i.e., 20-30seconds/tooth, at 0.5W power.
The method of the present disclosure for reducing the microbial load in the periodontal pockets above is used for improving the general oral hygiene of persons. 15
The method of the present disclosure for reducing the microbial load in the periodontal pockets above is also used for non-surgical management of chronic periodontitis.
DETAILED DESCRIPTION OF THE INVENTION
The present disclosure describes a novel method for improving oral hygiene and for the management of chronic periodontitis by reducing the harmful microbial load in the 20 periodontal pockets. The antimicrobial photodynamic method comprises the steps of:
a) Supra and sub gingival scaling and root planning is done in a person undergoing the method and the person is made to understand the routine oral hygiene instructions.
b) Preparation of photosensitizing dye by dissolving Indocyanine Green powder in Phosphate Buffered Saline (PBS) to obtain a solution of 250μg/ml concentration 25 within 1minute. The concentration of prepared dye should not increase beyond 250g/ml within 1 minute.
c) Application of the Indocyanine Green solution prepared in step (b) to the periodontal pockets of the person by filling the periodontal pockets by running the tip of the needle in a apical to coronal direction to avoid entrapment of bubbles. The 30
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Indocyanine Green dye applied is made to stay in the pocket for complete uptake of the dye. For this the dye should be left in periodontal pocket for 10 minutes only.
d) Drying off of any extra dye solution; and
e) Application of a 630nm diode laser on the periodontal pockets for illumination and activation of the dye in the pockets. For application of the laser light, the laser tip is 5 moved circumferentially in the test pockets around the tooth to target the following sites – mesio facial, mid facial, disto facial and lingual/palatal aspects of single rooted teeth and additional bifurcation and trifurcation areas in case of molars. The laser is applied in a continuous wave motion for 5 seconds/site i.e. 20-30seconds/tooth, at 0.5W power. 10
The following examples and comparative results described below demonstrate the effectiveness of the method of present disclosure.
Microbial samples were collected before and after the method from the person undergoing the method. The microbial samples collected were cultured, analysed and the results obtained were compared for effectiveness of the method. 15
Microbial sampling and analysis:
1. Initially the site of sample collection was isolated with cotton rolls, carefully cleaned with cotton pellets, and air-dried.
2. Plaque samples were obtained by insertion of two sterile paper points at the deepest part (bottom) of each periodontal pocket for a period of 20secs and then transferred to 20 Robertson’s Cooked Meat Medium (enriched with hemin & vitamin K) (HIMEDIA).
The pre- and post-treatment samples were carefully labelled.
3. The plates were incubated in an anaerobic jar at 37ºC under anaerobic conditions using ANC gas pack for 5 days. After 5days of incubation, the organisms were identified on the basis of anaerobic identification kit (Vitek 2, Biomerieux, France). 25
Example 1:
Full mouth supra gingival scaling was done on multiple persons After the initial sampling sub gingival scaling and root planning was completed.
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Photosensitizing Dye solution was prepared by dissolving reagent grade Indocyanine Green powder in Phosphate Buffered Saline (PBS) to obtain a solution of 250μg/ml concentration within 1minute. Care was taken that the concentration of the dye did not increase above 250μg/ml within 1 minute.
Step 3. A disposable 25gauge tuberculine syringe (with a side release cannula) was loaded 5 with the finished solution and made ready for use.
Step 4. The solution was made to fill the pockets at the test sites by running the tip of the needle in an apical to coronal direction to avoid entrapment of bubbles. It was made to stay in the pocket for 10mins for complete uptake of the dye to take place.
Step 5. Any extra solution was dried off. 10
Step 6. Laser application: A 630nm diode laser was used for illumination and activation of the dye in the pockets. The laser tip was moved circumferentially in the test pockets around the tooth to target the following sites – mesiofacial, midfacial, distofacial and lingual/palatal aspects of single rooted teeth and additional bifurcation and trifurcation areas in case of molars. The laser was used in a continuous wave motion for 5sec/site i.e. 20-30secs/tooth, at 15 0.5W power.
The microbial sampling was done using the sampling method described above. The samples collected before and after the application of the method were cultured and analysed using the method described above under “Microbial sampling and analysis”.
Test Results: 20
The effectiveness of the method of the present disclosure was measured in terms of Clinical Attachment Loss (CAL) (a sign of destructive physiologically irreversible periodontal disease) and basic clinical technique of periodontal probing. The following results were obtained:
Viswanath Venkatesh
IN/PA – 2121
Agent for the Applicant
6
Table 1: Shows the measurement of tissue damage before and after the application of the method (results based on the application of the method to 27 persons)
Initial
After 3 Months
P-value
Probing Depth(PD) (mm)
7.84 (7.33-8.19)
3.53 (3.33-4.11)
0.002
Clinical Attachment loss(CAL) (mm)
9.02 (7.50-9 20)
6.54 (5.70-6.61)
0.002
Table 2: Shows the measurement of tissue damage before and after the application of the method (results based on the application of the method to 7 persons) 5
Initial
After 3 Months
After 6 Months
PD
CAL
PD
CAL
PD
CAL
7.3
8.12
2.99
5.67
3.14
6.61
7.21
7.39
5.14
6.32
3.86
4.79
7.33
8.67
4.33
6.55
4.11
6.50
7.94
9.04
3.63
5.65
3.54
5.70
9.15
11.56
3.85
6.87
3.33
6.45
8.17
9.20
5.08
7.40
4.29
7.20
7.53
7.50
4.47
6.83
3.26
617
It is apparent from the above Tables 1 and 2 that after 3 and 6 months of the application of the method, the tissue damage due to periodontitis is reduced.
It will be apparent to a person skilled in the art that the above description is for illustrative purposes only and should not be considered as limiting. Various modifications, additions, 10 alterations, and improvements without deviating from the spirit and the scope of the invention may be made by a person skilled in the art and such modifications, additions, alterations, and improvements should be construed as being within the scope of this disclosure.
CLAIMS
We Claim:
1. A method for reducing the harmful microbial load in the periodontal pockets, wherein the method comprises the steps of:
a) Preparation of photosensitizing dye by dissolving Indocyanine Green powder in Phosphate Buffered Saline (PBS) to obtain a solution of 250μg/ml concentration within 1 minute;
b) Application of the Indocyanine Green solution prepared in step (a) to the periodontal pockets of the person undergoing the method using a disposable 10 25gauge tuberculine syringe (with a side release cannula) loaded with the dye, by filling the periodontal pockets, by running the tip of the needle in a apical to coronal direction to avoid entrapment of bubbles;
c) Allowing the Indocyanine Green dye applied in step (b) to stay in the periodontal pockets for 10 minutes;
d) Drying off of any extra dye solution applied to the periodontal pockets; and
e) Application of a 630nm diode laser on the periodontal pockets for illumination and activation of the dye in the pockets, wherein for application of the laser light, the laser tip is moved circumferentially in the test pockets around the tooth to target the mesio facial; mid facial; disto facial and lingual/palatal 20 aspects of single rooted teeth; and additional bifurcation and trifurcation areas in case of molars; and wherein the laser is applied in a continuous wave motion for 5 seconds/site, at 0.5W power;
wherein, the concentration of the Indocyanine Green dye is not more than 250μg/ml within 1 minute of its preparation and the dye is made to stay in the periodontal 25 pocket only for 10 minutes for complete uptake of the dye to take place.
2. The method for reducing the microbial load in the periodontal pockets as claimed in claim 1, wherein the method is used for improving the general oral hygiene of persons.
3. The method for reducing the microbial load in the periodontal pockets as claimed in claim 1, wherein the method is used for non-surgical management of chronic periodontitis.
4. A photosensitizing dye for reducing the harmful microbial load in the periodontal 35 pockets, said photosensitizing dye being prepared by dissolving Indocyanine Green powder in Phosphate Buffered Saline (PBS) to obtain a solution of 250μg/ml concentration within 1 minute
| # | Name | Date |
|---|---|---|
| 1 | 201811022441-FORM FOR STARTUP [15-06-2018(online)].pdf | 2018-06-15 |
| 2 | 201811022441-FORM FOR SMALL ENTITY(FORM-28) [15-06-2018(online)].pdf | 2018-06-15 |
| 3 | 201811022441-FORM 1 [15-06-2018(online)].pdf | 2018-06-15 |
| 4 | 201811022441-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [15-06-2018(online)].pdf | 2018-06-15 |
| 5 | 201811022441-EVIDENCE FOR REGISTRATION UNDER SSI [15-06-2018(online)].pdf | 2018-06-15 |
| 6 | 201811022441-DECLARATION OF INVENTORSHIP (FORM 5) [15-06-2018(online)].pdf | 2018-06-15 |
| 7 | 201811022441-COMPLETE SPECIFICATION [15-06-2018(online)].pdf | 2018-06-15 |
| 8 | 201811022441-Proof of Right (MANDATORY) [21-06-2018(online)].pdf | 2018-06-21 |
| 9 | 201811022441-FORM-26 [21-06-2018(online)].pdf | 2018-06-21 |
| 10 | 201811022441-ENDORSEMENT BY INVENTORS [21-06-2018(online)].pdf | 2018-06-21 |
| 11 | 201811022441-Power of Attorney-250618.pdf | 2018-07-02 |
| 12 | 201811022441-OTHERS-250618.pdf | 2018-07-02 |
| 13 | 201811022441-Form 5-250618.pdf | 2018-07-02 |
| 14 | 201811022441-Correspondence-250618.pdf | 2018-07-02 |
| 15 | 201811022441-OTHERS-270718.pdf | 2018-07-28 |
| 16 | 201811022441-Correspondence-270718.pdf | 2018-07-28 |