Comparison of the Effect of Gingival Massage of Aloe-vera Gel and Sidr Honey on Chronic Periodontitis. a Randomized Clinical Trial

Study Design The study is a Randomized controlled clinical trial. 3.2 Study Setting The study was carried out in the department of Periodontology at Dr.Ishrat-ul-Ebad Khan Institute of Oral Health Sciences.

3.3 Study Duration The duration of the study was 6-8 months after the synopsis approval. 3.4 Study Population The study was conducted on patients with Chronic Periodontitis. 3.4.1 Inclusion Criteria

1. Male/ female, 35-65 years of age with minimal 5 natural teeth in each quadrant excluding 3rd molars.

2. Patients having Chronic Periodontitis with probing depth 4 to 6mm and bleeding on probing in 20 sites.

3. Systematically healthy individuals with Chronic Periodontitis. 3.4.2 Exclusion Criteria

4. Individuals who smoke. 2. Any addiction of Areca nuts, gutka, paan or alcohol. 3. Individuals with any systemic diseases like diabetes mellitus, cardiovascular, endocrine as they may affect the outcome of research.

5. Women with pregnancy/lactation. 5. Individuals with any known allergy from aloe-vera or honey. 6. Systemic or topical use of antibiotic in past 6 months. 3.5 Sample Size Total of 105 patients were calculated (35 in each group) by using PASS V-11, Pair sample T-test with 95% Confidence Interval and 80% Power of test. Difference of plaque index at base line versus after 1 month mean (20.02) and standard deviation (68.16). Calculated sample size is 93, which is increased to 105.(26) 3.6 Sampling Technique The sampling technique was Non Probability consecutive sampling. 3.7 Data Collection Procedure Patients attending the Department of Periodontology were approached and examined for chronic periodontitis. Patients with chronic periodontitis were explained the research study procedure. Patient signing the consent form was enrolled in the study. All the enrolled participants went through a detailed history which includes medical health, systemic illness, regular medications, hospitalizations, any known allergies, dental checkups, any bad oral habit and routine oral hygiene practice. Any entrant having any allergy from honey or aloe-vera gel or anyone falling in our exclusion criteria were not selected in our research. All those who fulfilled our criteria were clinically examined and all the clinical parameters were recorded by the principal investigator at the baseline, i-e, pocket depth, gingival index, plaque index and bleeding on probing. Probing depth was recorded by Goldman-Fox probe with William's markings and flattened surface. Probing depth measurement was done by inserting probe on six sites on each tooth (mesial, distal, mid lingual, mid buccal, buccal and lingual), all the markings were measured from the marginal gingiva to the base of the periodontal pocket and were recorded in millimeters, if the tooth has recession and clinical attachment loss in any site of tooth it was not measured and was not included in our study. Bleeding on probing was checked on the buccal and lingual sulcus of tooth after inserting the probe and wait for 30 seconds, if bleeding occurs bleeding on probing was considered as 1 and labeled as positive bleeding on probing and if there is no bleeding it was considered as 0 and labeled as no bleeding on probing, Percentage of BOP was recorded by dividing positive bleeding sites by total number of sites present in each patient multiplied by 100. Gingival index (Loe and Silness, 1963) were recorded as score 0: Normal gingiva, 1: Mild inflammation on gingiva, 2: Moderate inflammation on gingiva and 3: Severe inflammation on gingiva. Plaque index (Loe and Silness, 1964) was recorded as score 0: No plaque, 1: plaque film on free gingival margin, 2: Moderate plaque on gingival margin; can be seen by the naked eye, 3: Abundance of soft matter in gingival pocket. After recording all the clinical parameters principal investigator performed non-surgical therapy (scaling and root debridement) by using ultrasonic scalers in single visit. Following scaling and root debridement the participants of all the three groups were given detailed oral hygiene instructions with demonstration of proper brushing technique i-e Modified Bass technique. After that all the participants were provided with a regular cleaning kit which consist of fluoride toothpaste (Colgate® Cavity Protection Toothpaste) and toothbrush (Colgate® Classic Clean Toothbrush) Moreover, all enrolled patients in Group A and B were minutely demonstrated by principal investigator for gingival massage.