The Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients

NCT05497895 | Unknown Early Phase 1 DMC

• 1 other identifier: KAAU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival diseases occur commonly in the global population and herbal products for its intervention have limited body of research evidence. This study to evaluate the clinical efficacy of 5% thymoquinone (TQ) gel as an adjunct to scaling and root planing (SRP) in patients diagnosed with gingivitis. OBJECTIVE: To evaluate the efficacy of 5% TQ gel using a novel liposome drug delivery as a topical application following SRP in gingivitis patients. DESIGN: Double-blinded, parallel, randomized controlled clinical trial. SETTING: Faculty of Dentistry, King Abdulaziz University, and Qassim University, Saudi Arabia

Conditions

Gingivitis

Keywords

Gingivitis; THYMOQUINONE; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Plaque index

  The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth: 0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2. Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  2 weeks

• Papillary bleeding index

  This index permits both immediate evaluation of the patient's gingival condition and his motivation, based upon the actual bleeding tendency of the gingival papillae. A periodontal probe is inserted into the gingival sulcus at the base of the papilla on the mesial aspect, and then moved coronally to the papilla tip. This is repeated on the distal aspect of the papilla. The intensity of any bleeding is recorded as: Score 0 - no bleeding; Score 1 - A single discreet bleeding point; Score 2 - Several isolated bleeding points or a single line of blood appears; Score 3 - The interdental triangle fills with blood shortly after probing; Score 4 - Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.

  2 weeks

Secondary Outcomes (2)

• Number of participants with drug related adverse events

  Duration of the clinical trial

• Number of participants non compliant/withdraw from the study

  Duration of the clinical trial

Study Arms (3)

Group I (SRP and TQ gel)

EXPERIMENTAL

In Group I patients, the lipid based TQ gel (5%) will be applied topically to the affected areas, twice daily for two weeks following SRP. The investigator performs the treatment of gingivitis based on the patient's response to therapy. For home care, the patients will be instructed to clean and dry the affected area prior to the gel application and hands will be washed prior and after its application. The patients will be instructed to not eat for 30 minutes following its application

Biological: 5% thymoquinone (TQ) gel

Group II (SRP and Placebo)

PLACEBO COMPARATOR

In Group II patients, the placebo gel will be applied topically to the affected areas, twice daily for two weeks following SRP. The investigator performs the treatment of gingivitis based on the patient's response to therapy. For home care, the patients will be instructed to clean and dry the affected area prior to the gel application and hands will be washed prior to and after its application. The patients will be instructed to not eat for 30 minutes following its application

Biological: SRP and placebo

Group III (Only SRP and one stage prophylaxis)

ACTIVE COMPARATOR

The Group III patients will be subjected to one-stage oral prophylaxis.

Procedure: Only SRP-one stage prophylaxis

Interventions

5% thymoquinone (TQ) gel BIOLOGICAL

Mode of Administration In Group I patients, the lipid based TQ gel (5%) will be applied topically to the affected areas, twice daily for two weeks following SRP. The investigator performing the treatment of gingivitis based on the patient's response to therapy. For home care, the patients will be instructed to clean and dry the affected area prior to the gel application and hands will be washed prior and after its application. The patients will be instructed to not eat for 30 minutes following its application.

Group I (SRP and TQ gel)

SRP and placebo BIOLOGICAL

In Group II patients, the placebo gel will be applied topically to the affected areas, twice daily for two weeks following SRP. The investigator performs the treatment of gingivitis based on the patient's response to therapy. For home care, the patients will be instructed to clean and dry the affected area prior to the gel application and hands will be washed prior to and after its application. The patients will be instructed to not eat for 30 minutes following its application

Group II (SRP and Placebo)

Only SRP-one stage prophylaxis PROCEDURE

The Group III patients will be subjected to one-stage oral prophylaxis.

Group III (Only SRP and one stage prophylaxis)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient diagnosed with gingivitis (Probing\<3mm with bleeding on probing ≥10% of sites) (Trombelli, Farina et al. 2018)
• Minimum twenty teeth in the oral cavity
• Age: 18-40 years

You may not qualify if:

• Patients with systemic diseases that have an association with periodontal diseases like diabetes, cardiovascular diseases, blood dyscrasias, or diseases of immune system and would require antibiotics prior to dental treatment
• Patients who received antibiotic therapy in the last 3 months prior to the trial
• Pregnant or lactating females
• Patients treated with drugs such as antacids, warfarin or cyclosporine
• Presence of overhanging restorations or other contributing factors to periodontal disease
• Allergy to Nigella sativa and/or TQ

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

Qassim University

Buraidah, 52571, Saudi Arabia

Location

Related Publications (1)

• Abou Sulaiman AE, Shehadeh RMH. Assessment of Total Antioxidant Capacity and the Use of Vitamin C in the Treatment of Non-Smokers With Chronic Periodontitis. J Periodontol. 2010 Nov;81(11):1547-54. Adair JG. The Hawthorne effect: A reconsideration of the methodological artifact. J Appl Psychol. 1984;69(2):334-45. Akalin FA, Toklu E, Renda N. Analysis of superoxide dismutase activity levels in gingiva and gingival crevicular fluid in patients with chronic periodontitis and periodontally healthy controls. J Clin Periodontol. 2005 Mar;32(3):238-43. Albandar JM, Brown LJ, Brunelle JA, Löe H. Gingival State and Dental Calculus in Early-Onset Periodontitis. J Periodontol. 1996 Oct;67(10):953-9. Al-Bayaty FH, Kamaruddin AA, Ismail MohdA, Abdulla MA. Formulation and Evaluation of a New Biodegradable Periodontal Chip Containing Thymoquinone in a Chitosan Base for the Management of Chronic Periodontitis. J Nanomater. 2013;2013:1-5. Al Wafi H. Benefits of Thymoquinone, a Nigella SativaExtract in Preventing Dental Caries Initiation and Improving Gingival Health. ProQuest LLC [Internet]. 2014; Available from: search.proquest.com Chapple ILC, Brock GR, Milward MR, Ling N, Matthews JB. Compromised GCF total antioxidant capacity in periodontitis: cause or effect? J Clin Periodontol [Internet]. 2007 Feb [cited 2020 Mar 26];34(2). Available from: http://doi.wiley.com/10.1111/j.1600-051X.2006.01029.x D'Aiuto F, Nibali L, Parkar M, Patel K, Suvan J, Donos N. Oxidative stress, systemic inflammation, and severe periodontitis. J Dent Res. 2010 Nov;89(11):1241-6. Feil PH, Grauer JS, Gadbury-Amyot CC, Kula K, McCunniff MD. Intentional use of the Hawthorne effect to improve oral hygiene compliance in orthodontic patients. Journal of dental education. 2002 Oct 1;66(10):1129-35. Idrees MM, Azzeghaiby SN, Hammad MM, Kujan OB. Prevalence and severity of plaque-induced gingivitis in a Saudi adult population. Saudi Med J. 2014 Nov;35(11):1373-7. Kataoka K, Ekuni D, Tomofuji T, Irie K, Kunitomo M, Uchida Y, et al. Visualization of Oxidative Stress Induced by Experimental Periodontitis in Keap1-Dependent Oxidative Stress Detector-Luciferase Mice. Int J Mol Sci. 2016 Nov 16;17(11):1907. Kandwal A, Mamgain R, Mamgain P. Comparative evaluation of turmeric gel with 2% chlorhexidine gluconate gel for treatment of plaque induced gingivitis: A randomized controlled clinical trial. AYU Int Q J Res Ayurveda. 2015;36(2):145. Kapil H, Suresh DK, Bathla SC, Arora KS. Assessment of clinical efficacy of locally delivered 0.2% Thymoquinone gel in the treatment of periodontitis. Saudi Dent J. 2018 Oct;30(4):348-54. Król K. [Reactive oxygen species and antioxidant mechanisms in the pathogenesis of periodontitis]. Ann Acad Med Stetin. 2004;50(2):135-48. Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov;38(6):610-6. Mariod AA, Ibrahim RM, Ismail M, Ismail N. Antioxidant activity and phenolic content of phenolic rich fractions obtained from black cumin (Nigella sativa) seedcake. Food Chem. 2009 Sep;116(1):306-12. Ozdemir H, Kara MI, Erciyas K, Ozer H, Ay S. Preventive effects of thymoquinone in a rat periodontitis model: a morphometric and histopathological study: Effects of thymoquinone in a rat periodontitis model. J Periodontal Res. 2012 Feb;47(1):74-80. Pihlstrom BL. Periodontal risk assessment, diagnosis and treatment planning. Periodontol 2000. 2001;25:37-58. Pradeep AR, Rao NS, Bajaj P, Agarwal E. 8-Isoprostane: A lipid peroxidation product in gingival crevicular fluid in healthy, gingivitis and chronic periodontitis subjects. Arch Oral Biol. 2013 May;58(5):500-4. Ragheb A, Attia A, Eldin W, Eibarbry F, Gazarin S, Shoker A. The protective effect of thymoquinone, an anti-oxidant and anti-inflammatory agent, against renal injury: a review. 2009;20(5):741. Saxer UP, Mühlemann HR. [Motivation and education]. Schweiz Monatsschrift Zahnheilkd Rev Mens Suisse Odonto-Stomatol. 1975 Sep;85(9):905-19. Sercombe L, Veerati T, Moheimani F, Wu SY, Sood AK, Hua S. Advances and Challenges of Liposome Assisted Drug Delivery. Front Pharmacol [Internet]. 2015 Dec 1 [cited 2020 Mar 26];6. Available from: http://journal.frontiersin.org/article/10.3389/fphar.2015.00286 Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Periodontol. 2018 Jun;89:S46-73.

  BACKGROUND

MeSH Terms

Conditions

Gingivitis

Interventions

thymoquinone; Gels

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ahmad AlMehmadi

  King Abdul Aziz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Almehmadi

CONTACT

+966561111056; ahmadkau@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: DESIGN: Double-blinded, parallel, randomized controlled clinical trial. SETTING: Faculty of Dentistry, King Abdulaziz University, and Qassim University, Saudi Arabia PARTICIPANTS AND METHODS: This trial will enroll 63 participants with age group between 18-40 years attending the outpatient clinics of Faculty of dentistry, Qassim University, Saudi Arabia with confirmed clinical diagnosis of gingivitis. The enrolled subjects will be categorized in three groups: Group I-TQ gel with SRP, Group II-Placebo with SRP, and Group III-SRP alone and clinical outcomes will be measured at baseline and two-week follow-up visit. MAIN OUTCOME MEASURES: Plaque Index (PI), Papillary Bleeding Index (PBI) and any adverse events with TQ gel categorized as mild, moderate, and severe. SAMPLE SIZE: 63 patients. Group I (n=21); Group II (n=21); Group III (n=21)

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: August 11, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

SA (1)