INTRODUCTION

           Periodontal diseases are chronic, multifactorial, microbial infection that usually destroys the periodontal tissues. The progressive destruction of the tooth-supporting structures are caused by the interactions between the microbial flora and the host inflammatory response.[1]

          Treating periodontal disease mainly aims on pathogenic microbial suppression in periodontal pocket  and  restoring the lost form and function which is achieved by means of conventional mechanical therapy like Scaling and Root Planing (SRP)[2]. It is difficult to perform mechanical debridement in deep periodontal pockets. Hence adjunctive use of local antimicrobial therapy [3] is preferred to systemic antibiotics, as it causes antimicrobial resistance, hypersensitivity, organ toxicity as higher concentrations are needed to reach the target site[4]. Various antimicrobials and antibiotics have been extensively studied for its clinical use as an adjuvant in periodontitis treatment for a long time[5,6], of which Chlorhexidine is found to be an effective antimicrobial agent[7].However, it is known to cause many side effects after prolonged use such as pigmentation of teeth and oral tissues.

           India is an age old heritage of traditional herbal medicines and the conventional drugs we are using today are known to cause increasing antimicrobial resistance. Hence there is constant need for newer drugs of which herbal drugs stand as an excellent alternative [8]. From ancient times, Ayurvedic drugs are used in treating periodontal disease. One such effective drug is Triphala which is used as a gargling agent since ancient times, according to the 20th shloka of  Sushrata  Sumhita (an ancient text on medicine and surgery in Sanskrit)[9].Triphala is obtained from the fruits of three medicinal plants namely Emblica officinalis, Terminalia chebula, and Terminalia belerica.It is found to have various properties like antibacterial, anti inflammatory, antiviral, antifungal, immunomodulatory, anti-oxidant, antimalarial, antiallergic, analgesic antimutagenic, anticancer , radioprotective,  cardiotonic, hypocholesterolemic, antihypertensive, capillary strengthening, hepatoprotective[10]. Triphala also has anti-collagenous activity by its inhibitory action on matrix metalloproteinase 9 (MMP 9).[11]

        Various studies have been made on Triphala as a mouth rinse which showed anti-plaque, anti-gingival activity and also effective in bleeding gums. However very limited studies have been made on Triphala as a local drug delivery agent and comparative studies on Triphala with other local drug delivery agents have not been made still now as of our knowledge. Hence , this study aims on comparing the efficacy of Triphala with Chlorhexidine as local drug delivery agent in the periodontal pocket as an adjunct to scaling and root planning for the treatment of chronic periodontitis .

                                                         AIM

            To evaluate and compare  the efficacy of  locally applied Triphala gel with Chlorhexidine gel as an adjunct to scaling and root planing for treatment of chronic periodontitis and Scaling & Root planning alone, through clinical parameters and microbiological studies.

                                                          OBJECTIVE

• To assess the efficacy of locally delivered Triphala in treatment of chronic periodontitis.

• To investigate the microbial count in periodontal pockets at baseline, 15 days,1 month. 

• To compare between the test and control sites for both clinical and microbiological parameters. 

                              REVIEW OF LITERATURE

            

         Sajith Abrahim et al (2005) conducted an invitro study to evaluate the inhibitory effect of Triphala on PMN type MMP-9. They extracted MMPs 10 patients gingival tissue sample with chronic periodontitis. Tissue extracts were treated with drug solutions Triphala , kamillosan and doxycycline and percentage of inhibition determined by gel documentation system. They found that Triphala showed 76.6% reduction of MMP 9 activity kamillosan and doxycycline showed 46.36% and 58.7% reduction of MMP 9 activity respectively. They concluded that Triphala had strong inhibitory activity on PMN-type MMPs which is involved in extracellular matrix degradation during periodontits[11].

 Desai et al (2010) conducted a clinical study to evaluate the efficacy of Triphala in 24 patients of 35-55yrs from OPD of dept. of periodontics . The patients were divided into group A - oral prophylaxis alone, group B -oral prophylaxis with chlorhexidine as mouth rinse, group C-oral prophylaxis with triphala as mouthrinse. Periodontal indices were recorded at baseline and 45days. They found that group B and group C showed significant reduction in periodontal indices when compared to group A and concluded that Triphala was found to be effective against gingivitis/periodontitis[12].

Bajaj N et al (2011) conducted a study on school students aged 8-12yrs to evaluate the effect of triphala on plaque.the patients were divided into 3 groups. Group I received 0.6% Triphala mouthwash, group II received Chlorhexidine mouthwash and Group III received distilled water (control group). Plaque scores were checked at baseline, 3, 6 and 9 months. They found that both group I and group II showed significant reduction in plaque scores from baseline till 9 months  and group III showed increase in plaque scores from baseline till 9months.Hence, concluded that Triphala was found to have antiplaque activity and effective against gingivitis[13].

   Naiktari et al (2014) conducted a clinical study to evaluate the efficacy of Triphala in 120 patients with gingivitis. The patients were grouped into group A (distilled water as mouth rinse), group B (chlorhexidine as a mouth rinse), group C ( Triphala as a mouth rinse). In all the three groups 10ml mouth rinse was used for 1 min twice daily. Plaque index and gingival index were checked at baseline and after 14 days. They found that group B and group C  showed significant reduction in plaque index and gingival index scores from baseline to after 14 days when compared to group A  and concluded that Triphala was found to be equally effective against gingivitis in comparison to chlorhexidine mouth rinse[14].

             Pradeep et al (2016) conducted a clinical study to evaluate the efficacy of Triphala in 90 patients of age 25-40 yrs with gingivitis. The patients were grouped into group 1 (scaling + placebo mouthwash), group 2 (scaling + Triphala mouthwash), group 3 (scaling + chlorhexidine mouthwash). In all the three groups’ 15 ml mouthwash was used twice daily, 30-45 min after brushing. Clinical Parameters and microbiological counts were checked at baseline and at 60 days. They found that significant reduction in plaque index, gingival index, oral hygiene – simplified index and microbiological counts from baseline to 60 days in Group 2 and group 3. They concluded that Triphala was comparable to Chlorhexidine and found to be effective against gingivitis both clinically and microbiologically [15].

                      Shivaprasad B.M. et al (2019) conducted a clinical study to evaluate the efficacy of Triphala as a local drug delivery agent in 13 chronic periodontitis patients. The target sites in patients were divided into 2 groups. Control sites received scaling and root planning alone and target sites received scaling and root planning with triphala gel as local drug delivery agent. Clinical parameters were evaluated at baseline, 15days and 1 month. Microbiological analysis for keystone periodontal pathogens Porphyromonas gingivalis,Fusobacerium nucleatum and Prevotella intermedia were done by anaerobic culture. The results showed that statistically significant intergroup difference in the clinical parameters between baseline and 1 month,the test group showing significantly higher change when compared to that of the control group. They concluded that subgingivally delivered Triphala has shown anticipative results revealing its slow and constant releasing property when used as an as an adjunct to SRP in the treatment of chronic periodontitis[16].

           Ketaki Bhor et al(2021) conducted a clinical study to compare the effect of 0.4% Triphala with 0.12% Chlorhexidine mouthwash on dental plaque,gingival inflammation and microbial count on Strept. Mutans,Strpt. Sanguis and Lactobacillus from plaque sample of schoolchildren 14-15yrs age.Children divided into 2 groups ,Group A receiving 0.4% Triphala and Group B 0.12% Chlorhexidine mouthwash.The clinical parameters and microbial count recorded at baseline,30 days and 90 days interval.They found significant decrease in all Plaque index,Gingival Index and microbial counts on both groups. They concluded that 0.4%Triphala and 0.12% Chlorhexidine has same inhibitory effect on plaque accumulation, gingivitis and growth of microorganisms [17].

                                     MATERIALS AND METHODS

STUDY DESIGN

A split mouth design will be used to evaluate the effectiveness of Triphala gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis in comparison to SRP followed by local application of chlorhexidine gel and SRP alone.

SOURCE OF DATA

The study will be conducted on patients attending OPD of Department of Periodontology at R.V.S Dental College and Hospital, Kumaran kottam, Kanampalayam,Sulur Coimbatore.

CONSENT 

Treatment protocol including the risks, benefits and clinical significance will be informed before obtaining consent from all the patients selected for the study.

ETHICAL CLEARENCE 

Permission from the institutional Ethical committee of R.V.S dental college and hospital were obtained before the commencement of the study.

METHOD OF COLLECTION OF DATA

SAMPLE SIZE – 90 sites from 30 patients will be selected and divided into three groups.

STUDY PERIOD – 3 Months.

SELECTION CRITERIA 

INCLUSION CRITERIA

Subjects with the following conditions will be included to participate in this study:

Subjects between 30-65 yrs of age  with chronic periodontitis

Subjects who are systemically healthy.

Subjects who have not received antibiotics or periodontal treatment for the past 3months. 

Subjects with not less than 20 natural teeth.

Subjects with Probing pocket depth (PPD) between 4 mm to 6mm (with at least 2 adjacent sites in each quadrant). 

EXCLUSION CRITERIA 

Subjects with the following conditions will be excluded to participate in this study:

Subjects with the history of chronic use of antibiotics/ anti- inflammatory drugs 3 months prior to the study.

Pregnant and lactating women.

Subjects with history of smoking or tobacco use.

Subjects with history of systemic diseases or other immunocompromised patients.

Subjects with history of periodontal therapy during the previous 6 months.

Subjects who are allergic to drugs.

ARMAMENTARIUM 

1. Mouth mirror

2. UNC 15 probe

3. Explorer

4. Triphala gel (Hiora GA)

5. Chlorhexidine gel (Hexigel)

6. Sterile container with Thioglycolate transport medium 

7. Universal curettes

8. COE-PAKTM regular set (GC AMERICA INC.)

PROCEDURE- CLINICAL PROTOCOL

Following Phase I therapy, using split mouth design each quadrant of the mouth are   randomly assigned into 3 groups, with each quadrant having atleast two adjacent sites between  PPD of 4mm to 6 mm.       

                            

Group I (Control):  30 Sites treated with Scaling and Root Planing alone.

Group II (Test group-1): 30 Sites treated with Scaling and Root Planing followed by local delivery of  Chlorhexidine gel.

Group III  (Test group-2): 30 Sites treated with Scaling and Root Planing followed by local delivery of Triphala gel.

                            CLINICAL PARAMETERS 

The following variables will be measured at baseline, 15th day and 1month.

1. Plaque index (PI) by Silness and Loe , 1964

2. Gingival index (GI) Loe and Silness, 1963

3. Sulcus bleeding index (BI) (Muhlemann and Son, 1971)

4. Probing pocket depth (PPD)   

5. Clinical attachment level (CAL)   

BASELINE INDEX SCORING:

    The plaque index, gingival index, sulcus bleeding index, PPD, CAL will be recorded on day 0, day 15 and day 30.

PLAQUE INDEX

The Plaque index given by Silness.P and Loe.H (1967) used for assessing the amount of plaque deposition at the gingival area of the index tooth.

GINGIVAL INDEX

The Gingival index given by Loe.H and Silness.P (1963)  used for assessing the status of inflammation of gingiva of the index tooth.

SULCUS BLEEDING INDEX

The Sulcus bleeding index given by (Muhlemann and Son, 1971) used for assessing the status of bleeding gums on the index tooth.

PROBING POCKET DEPTH

Probing pocket depth measured using UNC 15 probe, a 15mm long probe marked at each millimetre and color coded at the 5th, 10th and 15th millimetres. Periodontal pocket depth is the distance between the gingival margin and base of the periodontal pocket[18].

CLINICAL ATTACHMENT LEVEL (CAL)

CAL measured to monitor the progress of periodontitis. Level of attachment is the distance between the base of the pocket and a fixed point on the crown, such as the cemento-enamel junction (CEJ) [19].

TREATMENT PROCEDURE 

            Scaling and Root Planing will be performed after collection of plaque samples at baseline, thereafter the local drug delivery agent will be given subgingivally in persistent periodontal pockets between 4-6mm after revaluation of the periodontal status in the selected sites in the control and study groups after 2 weeks. 

All clinical parameters will be evaluated at baseline, 15 days and 1 month. Plaque samples in the sub gingival area will be collected by inserting the universal curette subgingivally into the deepest portion of the pocket parallel to the long axis of the tooth and scraped along the root surface by moving in a coronal direction [20] .

 

       The microbial sample will be stored in refrigerator and transported in a sterile container containing thioglycolate broth transport medium and sent for microbial colony counting.

After debridement, the test sites will be randomly divided .Those sites allocated to Group II will receive Chlorhexidine gel and Group III will receive Triphala gel, which will be delivered subgingivally in their respective test sites using a disposable syringe with a blunt cannula.

 

Following the placement, both the sites will be given a periodontal dressing with Coe pack, to retain the gel in the pocket. Patients asked to follow  regular oral hygiene practice and with caution in the dressing area.

 

 Patients will be recalled after 7days to remove the pack. Patients will be re-evaluated at 15th day and 30th day for clinical parameters and microbial sample collection using the same protocol.

The magnitude of patient’s response will be estimated at baseline, 15 days and at 1 month after treatment using the clinical and microbiological parameters.

MICROBIAL EXAMINATION

The microbial examination will be carried out using the plaque samples collected at baseline, 15days and 1 month to assess the number of microbial colony forming units (CFU).

STATISTICAL ANALYSIS

The data will be analysed using one-way ANOVA. Statistical significance will be reported when p<0.05.

REFERENCES :

1. Offenbacher S. Periodontal diseases: Pathogenesis. Ann Periodontol 1996;1:821-78.

2.Herrera D, Sanz M, Jepsen S, Needleman I, Roldán S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol 2002;29 Suppl 3:136-59

3. Van Winkelhoff AJ, Herrera Gonzales D, Winkel EG, Dellemijn-Kippuw N, Vandenbroucke-Grauls CM, Sanz M. Antimicrobial resistance in the subgingival microflora in patients with adult periodontitis. A comparison between the Netherlands and Spain. ZJ Clin Periodontol 2000;27:79-86.

4.. Behal R, Mali AM, Gilda SS, Paradkar AR. Evaluation of local drug-delivery system containing 2% whole turmeric gel used as an adjunct to scaling and root planning in chronic periodontitis: A clinical and microbiological study. J Indian Soc Periodontol 2011;15:35-8

5. Walker CB, Godowski KC, Borden L, Lennon J, Nangó S, Stone C, et al. The effects of sustained release doxycycline on the anaerobic flora and antibiotic resistant patterns in subgingival plaque and saliva. J Periodontol 2000;71:768-74. 

6. Elaine C.E, Gebara, Luiz A, Lima, Marcia P.A, Mayer. Propolis antimicrobial activity against periodontopathic bacteria. Braz J Microbiol 2002;33:365-9

7.  Divya PV, Nandakumar K. Local drug delivery periocol in periodontics. Trends Biomater Artif Organs 2006;19:74-80.

8. Tambekar DH, Dahikar SB, Lahare MD. Antibacterial potentials of some herbal preparations  available in India. Res J Med Med Sci 2009;4:224-7.

9. Sabina EP., Rasool M. An in vivo and in vitro potential of Indian ayurvedic herbal formulation triphala on experimental gouty arthritis in mice. VasculPharmacol 2008; //48: 14-20.

10.  Dr Rohit Jain, Dr Ranjana Mohan, Dr Janardhana Amarnath B, Dr Karthik Krishna M, Dr. Shalab Mehrotra, Dr Ruhi Mark. Herbs in periodontology – Local drug delivery.WJPR 2014;3(2):1831 40.

 11. Abraham S, Kumar MS, Sehgal PK, Nitish S, Jayakumar ND. Evaluation of the inhibitory effect of triphala on PMN type matrix metalloproteinase (MMP 9). J Periodontol 2005;76:497 502

12.Anupama Desai1 , Anil M2 , Surangama Debnath., A clinical trial to evaluate the effects of triphala as a mouthwash in comparison with chlorhexidine in chronic generalised periodontitis patient, Indian Journal of Dental Advancements ,2(3), July-September, 2010.

13. Neeti Bajaj, Shobha Tandon1, The effect of Triphala and Chlorhexidine mouthwash on dental plaque, gingival inflammation, and microbial growth., International Journal of Ayurveda Research ,January-March 2011 ,Vol 2 ,Issue 1.

14. Ritam S. Naiktari*, Pratima Gaonkar, Abhijit N. Gurav, Sujeet V. Khiste., A randomized clinical trial to evaluate eISSN 2093-2286 and compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized patients with periodontal diseases., J Periodontal Implant Sci 2014;44:134-140.

15. A.R. Pradeep,Deepak Kumar Suke,Santosh S. Martande, Sonender Pal Singh, Kanika Nagpal and Savitha B. Naik., Triphala, a New Herbal Mouthwash for the Treatment of Gingivitis: A Randomized Controlled Clinical Trial., J Periodontol • November 2016..

16. B. M. Shivaprasad, Padmavati Patil, Sruthi K. Nair, Navnita Singh, Shilpa Shivanand, Ume Sameera., Triphala: A phytomedicine for local drug delivery – A strategic intervention, An International Quarterly Journal of Research in Ayurveda., Volume 40, Issue 1 ,January-March 2019.

17. Ketaki Bhor, Vittaldas Shetty, Vikram Garcha, Kadambari Ambildhok, Vineet Vinay, Gargi Nimbulkar, Effect of 0.4% Triphala and 0.12% chlorhexidine mouthwash on dental plaque, gingival inflammation, and microbial growth in 14–15 year old schoolchildren: A randomized controlled clinical trial., Journal of Indian Society of Periodontology - Volume 25, Issue 6, November-December 2021.

18.Smith RG. A longitudinal study into the depth of the clinical gingival sulcus of human canine teeth during and after eruption. J Periodontal Res 1982;17:427-33.

19. Carranza FA, Takei HH. In: Newman MG, Takei HH, Kolkkevold PR, Carranza FA, editors. Diagnosis, Prognosis and Treatment Plan.11th ed. St. Louis: Saunder Elsevier; 

2006. p. 355.

20.Nagasri M, Madhulatha M, Musalaiah SV, Kumar PA, Krishna CH, Kumar PM. Efficacy of curcumin as an adjunct to scaling and root planing in chronic periodontitis patients: A clinical and microbiological study. J Pharm Bioallied Sci. 2015 Aug;7(Suppl 2):S554-8. doi: 10.4103/0975-7406.163537. PMID: 26538916; PMCID: PMC4606658.