CTRI

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CTRI Number

CTRI/2025/10/095677 [Registered on: 07/10/2025] Trial Registered Prospectively

Last Modified On:

06/10/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To clinically evaluate black cumin gel application as an adjunctive to periodontal Flap surgery in patients with severe gum disease.

Scientific Title of Study

Clinical evaluation of nigella sativa gel application as an adjunctive to periodontal flap surgery in stage three 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	Upputuri Venga Urekha
Designation	PG student
Affiliation	SIBAR INSTITUTE OF DENTAL SCIENCES
Address	Room no 8 Department of PeriodontologySibar Institute of Dental Sciences TakellapaduGuntur Room no 8 Department Of Periodontology Sibar Institute Of Dental SciencesTakellapadu Guntur Guntur ANDHRA PRADESH 522509 India
Phone	08639185751
Fax
Email	upputuriurekha@gmail.com

Details of Contact Person
Scientific Query

Name	Dr B Ramanarayana
Designation	Professor
Affiliation	SIBAR INSTITUTE OF DENTAL SCIENCES
Address	Room no 8 Department of Periodontology Sibar Institute Of Dental Sciences Takellapadu Guntur Room no 8oom Department of Periodontology Sibar Institute Of Dental Sciences Takellapadu Guntur Guntur ANDHRA PRADESH 522509 India
Phone	9490144365
Fax
Email	dr.ramanarayana@gmail.com

Details of Contact Person
Public Query

Name	Dr B Ramanarayana
Designation	Professor
Affiliation	SIBAR INSTITUTE OF DENTAL SCIENCES
Address	Room no 8, Department of Periodontology, Sibar Institute Of Dental sciences, Takellapadu,Guntur Room no 8, Department of Periodontology, Sibar Institute Of Dental Sciences , Takellapadu,Guntur Guntur ANDHRA PRADESH 522509 India
Phone	9490144365
Fax
Email	dr.ramanarayana@gmail.com

Source of Monetary or Material Support

Sibar institute of dental Sciences, takkellapadu, guntur, Andhra pradesh, India,522509

Primary Sponsor

Name	Upputuri Venga Urekha
Address	Room no 8, department of periodontology, sibar institute of dental sciences, takkellapadu, Guntur, Andhra pradesh, India,522509
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Upputuri Venga Urekha	Sibar institute of dental sciences	Room no 8, 2nd Floor, Department Of Periodontology, Sibar Institute Of Dental Sciences,Takellapadu Guntur ANDHRA PRADESH	08639185751 upputuriurekha@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sibar institute of dental sciences, Guntur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K053\|\|Chronic periodontitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	nigella sativa gel	After periodontal flap surgery gel will be applied on root surfaces clinical parameters will be recorded at baseline and 3 months
Comparator Agent	Without nigella sativa	After periodontal flap surgery gel will not be applied on root surfaces clinical parameters will be recorded at baseline and 3 months

Inclusion Criteria

Age From	30.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	Age group 30-55 years of both the gender Subjects who are apparently healthy. Subjects with maximum probing depth greater than 5mm, Clinical Attachment loss of greater 4mm in any quadrant Subjects who are willing to give informed consent.

ExclusionCriteria

Details

Subjects using any form of tobacco.
Patients with crowding of teeth.
Patients who had underwent any kind of periodontal surgery
History of previous antibiotic therapy within the past 3 months.
Subjects who have history of drug allergy.
Pregnant woman and Lactating mothers.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Measurement of Clinical Attachment level Probing Pocket Depth	At baseline and 3 months

Secondary Outcome

Outcome	TimePoints
Gingival index wound healing Index	baseline and 3 months

Target Sample Size

Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

Phase 4

Date of First Enrollment (India)

20/10/2025

Date of Study Completion (India)

30/01/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

This study is a randomized, parallel group clinical trial comparing the- clinical evaluation of nigella sativa gel application as an adjunctive to periodontal flap surgery in stage iii periodontitis patients . In 2023, The study tested the antibacterial effect of Nigella sativa (black seed) extract against Porphyromonas gingivalis, a major bacteria in gum disease. Six periodontitis patients (ages 30–50) were included. Laboratory tests showed that at 12.5 mg/ml, the extract had no effect, but at 25 mg/ml, it produced a 6.2 mm zone of inhibition, indicating antibacterial activity. The results suggest that Nigella sativa may be useful as a natural adjunct to scaling in periodontitis treatment.

Group 1: Periodontal flap surgery + application of nigella sativa

Group 2: Periodontal flap surgery alone