| CTRI Number |
CTRI/2024/09/074503 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Ozonated aloe vera gel in addition to teeth cleaning to cure severe gum diseases |
|
Scientific Title of Study
|
Effect of ozonated aloe vera gel application as an adjunctive to scaling and root planing in the treatment of stage II grade a periodontitis patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPedapudi Divya |
| Designation |
Postgraduate |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology Second floor Room number-8 Sibar Institute of Dental Sciences Takkellapadu
ANDHRA PRADESH
522509
India 9-2-110,Shyamala nagar 2 nd line,Guntur
9-2-110 ,Shyamala nagar 2 nd line , Guntur Guntur ANDHRA PRADESH 522509 India |
| Phone |
07330381395 |
| Fax |
|
| Email |
divyapedapudi998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Kishore Kumar |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology Second floor Room number-8 Sibar Institute of Dental Sciences Takkellapadu
ANDHRA PRADESH
522509
India
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr K Kishore Kumar |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology Second floor Room number-8 Sibar Institute of Dental Sciences Takkellapadu
ANDHRA PRADESH
522509
India
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sibar Institute Of Dental Sciences,
Takkellapadu
Guntur,
Andhra Pradesh,
India 522509 |
|
|
Primary Sponsor
|
| Name |
Pedapudi Divya |
| Address |
Department of Periodontology
Room number 8
Sibar Institute Of Dental Sciences
Takkellapadu
Guntur
Andhra Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pedapudi Divya |
Sibar Institute of Dental Sciences |
room no 8, 2nd floor, department of periodontology, Sibar insttute of dental sciences, takkellapadu, 522509 Guntur ANDHRA PRADESH |
7095132721
divyapedapudi998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2ml of Ozonated Aloevera gel |
Aloe vera is a cactus-like plant of Liliaceae family with about 360 species containing 75 active ingredients such as vitamins, enzymes, minerals, sugars, lignins, saponins, salicylic acids, and amino acids. Bhat et al examined the clinical effects of aloe vera gel during periodontal surgeries in patients with periodontal disease after mechanical debridement, reporting that topical aloe vera gel improved periodontal status; therefore, it can be used as a topical drug in periodontal pockets. Taking into considerations of effectiveness of aloe vera and ozone The present study was planned to observe the clincal outcomes with placement Ozonated aloe vera gel as an adjunct to scaling and root planing. Here 2ml of gel is placed once in the pockets after scaling and root planing. |
| Comparator Agent |
placebo |
2ml of non-ozonated aloevera gel is placed in the pockets as placebo. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Stage II Grade A periodontitis.
Subjects willing to participate in the study.
Subjects who are apparently healthy.
|
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers.
Allergic drug history .
Subjects who are under antibiotic therapy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level (CAL) gain |
Baseline, 1 month, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
Probing pocket depth |
Baseline, 1 month, 2 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis
is the chronic inflammation of the periodontium that extends
beyond the gingiva and involves the destruction of the tooth supporting
tissues. Gingivitis as the
early stage of this disease may turn into more severe periodontitis characterized
by pocket formation, alveolar bone destruction, and loss of clinical attachment
level. The first treatment goal in periodontal disease is changing or removing microbial origin and
risk factors to prevent disease progression and maintain periodontal tissue
health. Various host-response modulation therapies
and local drug therapies have been developed to block the pathways responsible
for periodontal tissue break down . Since bacterial products, immunological and
inflammatory factors are involved in the pathogenesis of periodontal disease,
some products as adjunctive therapy can be used to help the healing process or
controlling bacterial infection. Currently, ozone
therapy is gaining popularity as a modern non-invasive method of treatment , it
is a powerful oxidizing agent with a high antimicrobial power against oral
pathogens. Due to the fewer side effects
of medicinal herbs, some studies showed green tea, Cordiaverbenacea (a native plant of Brazil coasts) and Mikanialaevigata, per se or in
combination with SRP, can be beneficial in periodontitis treatment. Aloe vera is a cactus-like
plant of Liliaceae family with
about 360 species containing 75 active ingredients such as vitamins, enzymes,
minerals, sugars, lignins, saponins, salicylic acids, and amino acids. Bhat et al examined the clinical effects of aloe vera gel during
periodontal surgeries in patients with periodontal disease after mechanical
debridement, reporting that topical aloe vera gel improved periodontal status;
therefore, it can be used as a topical drug in periodontal pockets. Taking
into considerations of effectiveness of
aloe vera and ozone The present study was planned to observe the clincal
outcomes with placement Ozonated alovera gel as an adjunctive to scaling and root planing( SRP). At
initial visit, clinical examination will be performed on each patient and all
the clinical parameters will be recorded.
Patients who met the inclusion criteria are randomly
divided into Group I and Group II. All the patients will receive Phase 1
therapy followed by non surgical periodontal therapy. Patients in group I will
receive ozonated aloe vera gel application along with non surgical periodontal
therapy where as group II patients will receive Non Ozonated aloe vera gel
application with non surgical periodontal therapy.Patients were
instructed not to eat, drink, or rinse for at least 30 min and refrain from
chewing hard or sticky foods, brushing near the gel treated site or using
inter-dental aids. All clinical parameters are recorded at 30 and 60 days visit.
Reinforcement of oral hygiene instructions at each appointment will be done. |