Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607535790876 Date of Registration: 22/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Locally Delivered Black Seed Oil Gel (Nigella Sativa) as an Adjunctive To Non-Surgical Treatment in Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial
Official scientific title Efficacy of Locally Delivered Black Seed Oil Gel (Nigella Sativa) as an Adjunctive To Non-Surgical Treatment in Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Periodontitis is a chronic inflammatory disease associated with a dysbiotic subgingival biofilm and progressive destruction of the tooth-supporting tissues. Scaling and root planing is the standard nonsurgical periodontal treatment; however, mechanical debridement alone may not completely eliminate periodontal pathogens or adequately control inflammation. Consequently, locally delivered antimicrobial agents have been proposed as adjuncts to improve periodontal treatment outcomes while reducing the adverse effects associated with systemic medications. *Nigella sativa* (black seed) contains biologically active constituents, particularly thymoquinone, with reported antimicrobial, anti-inflammatory, and antioxidant properties. These properties may support its use as a locally delivered adjunctive treatment for periodontitis. The objective of this randomized controlled clinical trial is to evaluate the clinical and microbiological efficacy of locally delivered *Nigella sativa* oil gel as an adjunct to scaling and root planing in patients with Stage II, Grade B periodontitis. The intervention will be compared with scaling and root planing combined with a placebo gel. Clinical outcomes will include probing pocket depth, clinical attachment level, bleeding on probing, and gingival index. Microbiological efficacy will be assessed by measuring *Porphyromonas gingivalis* levels using quantitative polymerase chain reaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2025
Actual trial start date 20/03/2025
Anticipated date of last follow up 20/09/2025
Actual Last follow-up date 20/12/2025
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo gel Gel application will be carried out 3 times throughout the study period, immediately after SRP, one week, and two weeks from the first injection. 3 month Fifteen sites will receive conventional treatment including full mouth scaling and root planing (SRP) + application of Placebo gel into the pocket of the selected sites 3 times throughout the study period 15 Active-Treatment of Control Group
Experimental Group Nigella sativa gel Gel application will be carried out 3 times throughout the study period, immediately after SRP, one week, and two weeks from the first injection. 3 month Fifteen sites will receive conventional treatment including full mouth scaling and root planing (SRP) + application of Nigella sativa gel into the pocket of the selected sites 3 times throughout the study period 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ages from 30 : 55 years Medically free patient Probing pocket depth (PPD) ≥ 5 Clinical attachment loss 3-4 mm. Optimal compliance as evidenced by no missing appointments and positive attitude towards oral hygiene. Current smoker patients. 2Patients with traumatic occlusion unless receiving adequate treatment. Gingival recession Patients consuming antibiotics in the last three months. Patients with any other periodontal treatment for at least 6 months ago. 6. Pregnant and lactating females Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/02/2025 Internal research ethicscommitte faculty of dentistryTanta university
Ethics Committee Address
Street address City Postal code Country
el bahr street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Microbiological Assessment : Quantitative polymerase chain reaction (qPCR) used to count the number of porphyromonas gingivalis baseline and 3 month after treatment
Secondary Outcome probing pocket depth baseline , 1 month , 3 month after treatment
Secondary Outcome clinical attachment loss baseline , 1month and 3 month after treatment
Secondary Outcome bleeding on probing baseline , 1 month and 3 month after treatment
Secondary Outcome gingival index baseline , 1month and 3 month after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of dentistryTanta university el bahr street Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Adel Elmalla el gaish street Tanta 31773 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed AdelE lmalla ELgaish street Tanta 31773 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Adel Elmalla ahmedadelelmalla1996@gmail.com 01116831618 Elgaish street
City Postal code Country Position/Affiliation
Tanta 31773 Egypt external researcher
Role Name Email Phone Street address
Public Enquiries Doaa Ahmed Yousef doaa.bayoumi@dent.tanta.edu.eg 01006882900 Elgaish street
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Mona ElMeligy mona.elmeligy@dent.tanta.edu.eg 01009582493 ELgaish street
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individualparticipant data underlyingthe published results may beavailable upon reasonablerequest after completion ofthe trial and publication of themain findings. Shared datawill not include personalidentifiers, radiographicimages with identifiableinformation, or any data thatmay compromise participantconfidentiality Informed Consent Form,Study Protocol Data may be available beginning 6 months after publication of the main trial results and for 3 years thereafter Data will be shared only upon reasonable written request for scientific purposes, after approval by the principal investigator and research ethics committee when required. Requesters must provide a clear research proposal and sign a data confidentiality agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information