Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05231096 |
| Other study ID # |
30071991 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2019 |
| Est. completion date |
October 15, 2020 |
Study information
| Verified date |
February 2022 |
| Source |
Dow University of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic Periodontitis is an inflammatory condition and a common disease worldwide. Honey has
been used in dentistry for its beneficial properties. It has been used in many oral
conditions like gingivitis and periodontal diseases for its antibacterial and healing
properties, on the other hand, aloe vera gel is known for its anti-inflammatory aspects, and
it has been used in dentistry for its potential advantages.
Objective The main objective of the study was to find out the effects of gingival massage
with aloe-vera gel and sidr honey as adjunct to non surgical therapy after one month in
patients with Chronic periodontitis and to find out whether there is a difference in the
efficacy of aloe-vera gel and sidr honey in reducing plaque index, gingival index, pocket
depth and bleeding on probing after one month of gingival massage when used as adjunct to
non-surgical therapy.
Method 105 patients with chronic periodontitis were selected in this single-blinded
Randomized control clinical trial. At recruitment non-surgical therapy i-e scaling and root
debridement was performed. At baseline all clinical parameters, gingival index, plaque index,
bleeding on probing and pocket depths were recorded. All the participants were then randomly
divided in three groups, Group A: SRD & Gingival massage with Aloe-vera gel, Group B: SRD &
Gingival massage with Sidr honey and Group C SRD only. On 30th day of trial all the patients
were re-examined for all the clinical parameters.
Statistical Analysis SPSS version 21 was used for data entry and analysis with significance
level set at Ƥ <0.05. Median, median difference and Inter Quartile ranges were reported for
plaque index, gingival index, probing depth and percentages were reported for bleeding on
probing. Wilcoxon Signed rank test was used for pre and post comparison. Mann Whitney test
was applied for comparison between groups.
Description:
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
1. 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.
4. 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.
Aloe-Vera gel Production Aloe vera gel used in this study was 98% aloe vera gel concentration
and 2% normal saline. Preparation of aloe-vera gel consists of ripen leaf of aloe vera.(26)
Aloe vera leaf was washed thoroughly under water and then cut from the center and the seeping
gel was collected in sterile container and was stored at 4°C until the time of application.
In our research this pure Aloe vera gel was extracted by The Pakistan Council of Scientific &
Industrial Research (PCSIR) laboratory.
Honey collection Sidr (Beri) honey was used in this study. Honey was thick, raw and cold
extracted from remote Pakistan afghan tribal forest belt of Sidr trees. It was smooth,
viscous and medium to dark amber in color.
Random Allocation of the Intervention A total of 105 participants were divided in to three
groups and were named as Group A: SRD & Gingival massage with Aloe-Vera gel, Group B: SRD &
Gingival massage with Sidr honey and group C: SRD only. Interventions were randomly
allocated. For this purpose, entrants were asked to pick one sealed opaque envelope in which
random allocation of the interventions were mentioned. All the participants who were in Group
A and B were not blinded and trained for gingival massage by principal investigator. All the
participants were guided to rub aloe-vera gel or sidr honey on the skin of wrist first to
recheck any allergy. At last participants were trained for application of the material gently
on the gingiva and the gingival sulcus of all the teeth. To perform gingival massage patients
used the index finger of their dominant hand, applied the material at the bottom of their
gums with slight pressure, then moved the finger in a slow and circular motion/rubbing action
for 1 to 3 minutes, after performing the massage patients were not allowed to rinse with
water or any other fluids for 30 minutes for further retaining the material on the gingiva
and in the gingival sulcus thereby preventing washing out of the material. All the patients
were instructed to perform gingival massage with aloe-vera gel and sidr honey twice a day
after meals and to wait for 30 minutes after application of the interventions. All the
routine oral hygiene practice which includes brushing twice a day (morning and night) was
continued as usual. Patients falling in the control group were instructed to follow routine
oral hygiene protocols. Telephonic communications were made weekly for encouraging the
patients for gingival massage with given interventions. All the patients were recalled on
30th day for Post-intervention assessment. The baseline clinical parameters were recorded by
principal investigator whereas 1 month follow-up of all clinical parameters were recorded by
a trained examiner in this study. Intra-examiner reliability was checked to ensure
calibration between examiners. For this purpose both examiners recorded clinical parameters
of 50 subjects with chronic periodontitis who were not involved in our study and reliability
came out to be 88%. The trained examiner who was blinded from the intervention given to
patients was asked to re-assess all the clinical parameters which included periodontal pocket
depth, gingival index, plaque index and bleeding on probing.
