Assess the use of Gum-paint and Tablets applied over gums along with Cleaning in Diabetic patients with Gum Disease.

Phase 4

Completed

Conditions: Diabetic patients with Chronic Periodontitis

Registration Number: CTRI/2018/03/012726

Lead Sponsor: Alarsin Pharmaceuticals

Brief Summary: Periodontitishas been identified as the sixth complication of diabetes1. Diabeteshas become a global epidemic. Its complications can have a significant impacton quality of life, longevity, and public health costs. The presence ofdiabetes might impair the prognosis of periodontal treatments due to itsnegative influence on wound healing.

Periodontaldiseases are a group of inflammatory conditions resulting from

interaction between apathogenic bacterial biofilm and susceptible hostâ€™s

inflammatory responseeventually leading to the destruction of periodontal structures

and subsequent toothloss. Inflammation is an immunologic response involving blood vessels and bloodcells to local injury, infection, hypersensitivity, physical reaction, chemicalreaction, necrosis of tissues and emotional stress.

Scalingis considered as the gold standard treatment for these conditions2.As an adjunct to scaling many chemical and herbal formulations have been triedand found to be efficacious in the past. Chemical preparations are known tocause conditions such as drug resistance with reports of drug allergy alongwith staining of teeth, and thus a shift toward the herbal remedies has beenseen in the near past and gaining popularity in present.

From the dawn of history man has sought to curediseases with use of medicinal plants. Ayurveda is believed to have developedsomewhere during the period 2800-500 B.C. In India, systematic work onscientific lines of herbal medicines was organised by Sir R.M. Chopra. In thefield of dentistry few herbal medicines have been showing encouraging results.Use of tannic acid have been advocated for the treatment of gingivitis. Use ofneem as datun has been advised for freshening the mouth.

G32TM is an ayurvedic preparationmarketed by ALARSIN. G32TM has beendescribed as having antiseptic, anti-inflammatory, astringent, styptic, anodyneand other properties. G32TM, used in this study,is one such *ayurvedic* preparation. It is available for localapplication, in an easily crushable tablet form and as gum paint. The mainingredients in this *ayurvedic* preparation include *Bakul, Chok, Katha,Laving,* *Fatakdi,* etc.

**Constituents of** **G32TM**

*Bakul* (*Mimosopselangi)* - 80 mg.

*Chok* (CalciumCarbonate) - 75 mg.

*Katho* (*Acaciacatechu)* - 40 mg.

*Laving* (*Myrtuscaryophyllus)* - 20 mg.

*Chikani Sopari* (*Arecacatechu)* - 20 mg.

*Fatakadi* (Alumen)- 20 mg.

*Mayafal* (*Quercusinfectoria)* - 20 mg.

*Elaichi* (*Elettariacardamomum)* - 10 mg.

*Sonageru* (Silicateof Alumina and Iron Oxide) - 10 mg.

*Jiru* (*Carumcarvi)* - 10 mg.

*Majith* (*Rubiacordifolia)* - 10 mg.

*Pashanbed* (*Saxifrualigulata)* - 10 mg.

*Vavding* (*Embelia ribes)* - 10 mg.

*Pipala ni Lakh* (*Ficus* *religiosa)*- 10 mg.

*Samudrafin* (*Os sapiae)* - 10 mg.

*Vajradanti* (*Barleriaprioitis)* - 10 mg.

*Taj* (*Cinnamimumcassia)* - 5 mg.

*Mari* (*Pipernigrum)* - 5 mg.

*Sajikhar* (Sodiumcarbonate impure) - 5 mg.

*Kulinjan* (*Alpiniachinensis)* - 5 mg.

*Pipar* (*Piperlongum)* - 5 mg.

*Kapur* (*Camphoraofficinarum)* - 5 mg.

*Kuth* (*Uncariagambier)* - 5 mg.

G32TM can be used for gum massage, dentrifice,rinse and gargle. G32TM is found to be an effective and asafe drug in gingivitis, acute or chronic, localisedor generalised, and even when associated with painfulteeth and bleeding gums.6

**AIMOF STUDY:**

To introduce a naturaladjunct that effectively reduces inflammation in Diabetic patients with ChronicPeriodontitis

**OBJECTIVESOF THE STUDY:**

1. Toevaluate the efficacy of G32TM gum paint and tablets as an adjunctto Scaling in Diabetic patients with Chronic.

2. Tocompare the efficacy of G32TM gum paint with tablets in Diabeticpatients with Chronic Periodontitis post scaling Periodontitis

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Age group between 25-70 years.
2.Patients with controlled diabetes (on oral hypoglycemic drugs) with glycosylated haemoglobin (HbA1c) levels < 7 3.Patients with chronic periodontitis having periodontal pocket depth less than 4mm 4.Patients with minimum of 20 teeth.
5.Patients who have not received any type of periodontal therapy for the past 6 months.

Exclusion Criteria

1.Patients on insulin therapy 2.Patients suffering from any other systemic disease or with compromised immune system.
3.Patients with a known history of drug allergy 4.Patients taking any drug known to cause gingival enlargement 5.Patients taking any immuno-suppressive drugs like corticosteroids.
6.Pregnant and/or lactating mothers.
7.Patients with any bleeding disorders.
9.Patients with smoking and tobacco chewing habits.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study will help to evaluate an adjunct to scaling in Diabetic patients with Chronic Periodontitis for control or regression of gingival inflammation.	Baseline and 1 month follow up

Secondary Outcome Measures

Name	Time	Method
Reduction of gingival, plaque scores, probing pocket depth and clinical attachment loss	Baseline and 1 month follow up

Trial Locations

Locations (1): Nair Hospital Dental College
🇮🇳
Mumbai, MAHARASHTRA, India
Nair Hospital Dental College
🇮🇳Mumbai, MAHARASHTRA, India
Dr Shraddha Kode
Principal investigator
9773752150
kshraa24@gmail.com