| CTRI Number |
CTRI/2025/07/090645 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparison of how well mouth gels made from oregano oil, magnolia oil, cranberry oil, and tea tree oil work when used directly on the gums to treat early to moderate gum disease. |
|
Scientific Title of Study
|
Comparative evaluation of clinical efficacy of Origanum oil, Magnolia oil, Cranberry oil and Tea tree oil oral in-situ gels as local drug delivery in the treatment of Stage -I and Stage-II Periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India, PINCODE-522509 |
|
|
Primary Sponsor
|
| Name |
Dr Boyapati Ramanarayana |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar
Institute of Dental Sciences, Takkellapadu, Guntur, Andhra
Pradesh,India, PIN CODE-522509 |
| 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 Boyapati Ramanarayana |
Sibar Institute of Dental Sciences |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, PIN CODE-522509 India
Guntur
ANDHRA PRADESH |
09490144365
dr.ramanarayana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sibar Institute of Dental Sciences, Guntur |
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 |
Magnolia officinalis oil oral in-situ gel |
Magnolol is a binaphthalene polyphenolic compound, isolated from the stem bark of Magnolia officinalis, being a traditional extract, used mainly in Chinese medicine. Magnolol exerts a wide variety of beneficial pharmacological activities. Magnolia officinalis extract has plentiful attributes, such as anti-inflammatory, antioxidant, antibacterial, anti-osteoclastic, antianxiety, anti-diabetic, antiplatelet, and anticarcinogenic |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Origanum vulgare oil oral in-situ gel |
Carvacrol is a phenolic monoterpenoid, produced by many herbs, the best known of which are Origanum vulgare. Carvacrol has long been recognized as a component of oregano essential oil, being one of its most investigated components. Thymol is a structural isomer of carvacrol, with the hydroxyl group (–OH) in the second position and similar characteristics to those of carvacrol. Carvacrol possesses anti-inflammatory, antioxidant, and antibacterial properties. At the same time, carvacrol has other biological properties, being anti-diabetic, antifungal, antitumor, antimutagenic, analgesic, anti-hepatotoxic, cardioprotective, and antiparasitic. |
| Intervention |
Tea tree oil oral in-situ gel |
Tea tree oil (TTO) is an herbal remedy with antibacterial, anti-inflammatory, antifungal, antiviral, and antioxidant properties. Studies demonstrated the benefits of using this medication locally to treat periodontal disorders. 1,8-cineole and terpinen-4-ol are the two most significant active components of TTO. Common herbal essential oils, like eucalyptus and fennel oil, make up these ingredients. Since it can penetrate human skin, 1,8-cineole has anti-inflammatory qualities. Terpinen-4-ol has the same antibacterial and anti-inflammatory qualities as 1,8-cineol. The administration of TTO revealed similar antimicrobial properties to chlorhexidine (CHX), but through different mechanisms. The antibacterial, antiviral, and antifungal properties are also present |
| Intervention |
Vaccinium macrocarpon oil oral in-situ gel |
Cranberry (Vaccinium macrocarpon oil ) itself is a unique, rich source of several classes of bioactive flavonoids including flavanols, anthocyanins, and proanthocyanidins which confer it the significant therapeutic potential. Experimentally, Labreque in 2006 and Yamanaka in 2008 revealed that the NDM fraction of cranberry hindered the colonization of by Porphyromonas gingivalis and Fusobacterium nucleatum in the gingival crevice. Besides, it also prevented the adhesion of P. gingivalis to various proteins including type I collagen thus reducing bacterial coaggregation in periodontal diseases. Cranberries were reported to restrain the proteolytic activity of the red complex specifically the gingipain activity of P. gingivalis, trypsin like activity of Tanerella forsythia and chemotrypsin like activity of T. denticola. Proanthocyanidins are extracted from cranberries the fruit and are the most abundant flavonoid among the ingredients.They are anti-bacterial, anti-adhesion, antioxidant, and anti-inflammatory. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Stage I and Stage II Periodontitis.
2.Patients within the age group of 30 to 55 years of age for both genders.
3.Subjects with no history of allergies to the components used in the study
4.Apparently healthy individuals
5.Patients who are willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with habits like any form of tobacco, or alcohol consumption.
2.Systemically compromised patients
3.Pregnant women or lactating mothers
4.Patients who are on medication that influences Periodontal health.
5.Patients who will not be able to be attend for follow up visits
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in clinical attachment level
2.Reduction of Periodontal Pocket Probing Depth |
baseline,1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| better wound healing (PISA index) |
baseline,1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Periodontal
disease is a significant global public health concern affecting individuals
across all demographics. It encompasses inflammatory conditions like gingivitis
and periodontitis, with the latter leading to irreversible damage such as
alveolar bone resorption and periodontal ligament detachment. The disease is
primarily initiated by gram-negative bacterial colonization, which stimulates a
destructive host immune response through the release of pro-inflammatory
mediators like IL-1 and PGE2.
Traditional
treatment through scaling and root planing (SRP) helps reduce microbial load
but is limited in accessing deeper periodontal pockets. Although systemic
antibiotics are effective, they pose risks such as antibiotic resistance and
secondary infections. To overcome these limitations, localized drug delivery
systems have gained attention, offering targeted treatment with fewer systemic
side effects. However, many synthetic agents still cause undesirable effects
like gastrointestinal distress and tooth staining.
As
a result, attention has shifted to phytotherapy, which explores natural
plant-based agents with antimicrobial and anti-inflammatory properties. Several
herbal compounds have demonstrated potential in periodontal therapy. Carvacrol,
derived from Origanum vulgare, exhibits antibacterial, anti-inflammatory, and
antioxidant properties. Magnolol, a bioactive compound from Magnolia
officinalis, shows diverse pharmacological benefits including antibacterial and
anti-inflammatory actions. Cranberry extracts, particularly rich in
proanthocyanidins, hinder bacterial adhesion and proteolytic activity of key
periodontopathogens. Tea tree oil, containing active constituents like
1,8-cineole and terpinen-4-ol, demonstrates antimicrobial efficacy comparable
to chlorhexidine with a different mechanism of action and better
biocompatibility.
Given
these promising properties, the present study proposes to evaluate and compare
the clinical efficacy of in situ oral gels formulated from Carvacrol (Origanum
vulgare oil), Magnolol (Magnolia officinalis oil), Vaccinium macrocarpon
(cranberry) oil, and Tea Tree Oil as adjuncts to SRP in managing Stage-1 and
Stage-2 periodontitis. These natural alternatives may offer effective
periodontal therapy with fewer adverse effects. |