GingivitisEarly Phase 1NCT05497895
The Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients
A Early Phase 1 study testing 5% thymoquinone (TQ) gel and Only SRP-one stage prophylaxis in people with Gingivitis, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- 5% thymoquinone (TQ) gel and Only SRP-one stage prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2022to Nov 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial for the Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients
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
Read the detailed description
This randomized controlled clinical trial will be conducted to evaluate of clinical efficacy of TQ gel (5%) as an adjunct to SRP in patients with gingivitis (n=63). The patients will be recruited from the Faculty of Dentistry, Qassim University and the subjects will be divided into three groups and include Group I (SRP+TQ gel), Group II (SRP+Placebo), and Group III (Only SRP-one stage prophylaxis). The subjects will be given an explanation of the purpose of the study; informed consent will be obtained in a written format. This clinical trial will be performed in accordance with the ICH (International Conference on Harmonization-E6 'Guideline for Good Clinical Practice') and Helsinki Declaration 1975, as revised in 2000. The study protocol was approved by the Institutional Review Board, Qassim University, Saudi Arabia (IRB No: EAC 104-2018). The complete oral diagnosis will be performed during the screening visit by clinical assessment and periapical radiographs may be indicated to obtain a definitive diagnosis, The periodontal charting will be performed and recorded in the patient's case record. The participants will be consecutively enrolled with the following inclusion and exclusion criteria.
Preparation of Lipid-based TQ gel formulation (5%):
Thymoquinone extract (Sigma Aldrich extract-Product No:03416) was obtained in crystalline form.
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 will perform 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 to be washed prior to and after its application. The patients would be instructed to not eat for 30 minutes following its application. The same will be done for Group II patients who were treated with SRP followed by a placebo gel application in the affected areas. The Group III patients will be subjected to one-stage oral prophylaxis. It will be a double-blinded clinical trial as the patients would not be made aware of which gel preparation was given to them and the principal investigators would not be aware of the patient's group while performing clinical measurements, whereas the operator performed SRP and gel application.
Treatment Compliance A diary card will be given to all the patients along with instructions on filling the card and reminders to bring it on subsequent visits will be mentioned. The principal investigator will ensure that each patient used at least 75% and not more than 125% of the study drug over the course of the study period. The drug accountability i.e., receipt, dispensing, and return of the drug) will be performed either by the principal investigator or his designee. The assessment of the primary endpoint will be based on the clinical scoring conducted on a weekly basis till the end of the study.
Clinical Evaluation The clinical parameters such as plaque index (PI) and papillary bleeding index (PBI) will be evaluated for all the patients at the appropriate follow-up intervals. The parameters will be evaluated by two independent examiners. The adverse events, if any with the administration of TQ gel will be monitored and it would be graded as per the intensity as mild, moderate, and severe.
Discontinuation of Treatment In case of adverse events with the use of the study drug, the patients would be withdrawn from therapy or clinical assessment. Also, when the patients suffer from significant illness or undergo surgery during the course of the study, they would be withdrawn from the trial. The non-compliant patients who did not adhere to the study protocol or for other justifiable reasons were withdrawn from the current clinical trial.
- Conditions
- Gingivitis
- Being tested
- 5% thymoquinone (TQ) gel, SRP and placebo, Only SRP-one stage prophylaxis
- Keywords
- Gingivitis, THYMOQUINONE, Clinical Trial
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% thymoquinone (TQ) gelBiological
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.
SRP and placeboBiological
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
Only SRP-one stage prophylaxisProcedure or surgery
The Group III patients will be subjected to one-stage oral prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Procedure: Only SRP-one stage prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
- Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (2)
Number of participants with drug related adverse events
Reported during the trial and on clinical assessment
Measured: Duration of the clinical trial
Number of participants non compliant/withdraw from the study
Reported during the trial
Measured: Duration of the clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Almehmadi, King Abdulaziz University
- Investigators
- Ahmad AlMehmadi, Principal investigator, King Abdul Aziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497895
- Sponsor's protocol ID
- KAAU
- Status last verified
- Aug 2022
- First submitted
- 17 Jun 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial for the Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients
- ClinicalTrials.gov ID
- NCT05497895
- Acronym / sponsor ID
- KAAU
- Conditions
- Gingivitis
- Keywords
- Gingivitis, THYMOQUINONE, Clinical Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This randomized controlled clinical trial will be conducted to evaluate of clinical efficacy of TQ gel (5%) as an adjunct to SRP in patients with gingivitis (n=63). The patients will be recruited from the Faculty of Dentistry, Qassim University and the subjects will be divided into three groups and include Group I (SRP+TQ gel), Group II (SRP+Placebo), and Group III (Only SRP-one stage prophylaxis). The subjects will be given an explanation of the purpose of the study; informed consent will be obtained in a written format. This clinical trial will be performed in accordance with the ICH (International Conference on Harmonization-E6 'Guideline for Good Clinical Practice') and Helsinki Declaration 1975, as revised in 2000. The study protocol was approved by the Institutional Review Board, Qassim University, Saudi Arabia (IRB No: EAC 104-2018). The complete oral diagnosis will be performed during the screening visit by clinical assessment and periapical radiographs may be indicated to obtain a definitive diagnosis, The periodontal charting will be performed and recorded in the patient's case record. The participants will be consecutively enrolled with the following inclusion and exclusion criteria.
Preparation of Lipid-based TQ gel formulation (5%):
Thymoquinone extract (Sigma Aldrich extract-Product No:03416) was obtained in crystalline form.
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 will perform 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 to be washed prior to and after its application. The patients would be instructed to not eat for 30 minutes following its application. The same will be done for Group II patients who were treated with SRP followed by a placebo gel application in the affected areas. The Group III patients will be subjected to one-stage oral prophylaxis. It will be a double-blinded clinical trial as the patients would not be made aware of which gel preparation was given to them and the principal investigators would not be aware of the patient's group while performing clinical measurements, whereas the operator performed SRP and gel application.
Treatment Compliance A diary card will be given to all the patients along with instructions on filling the card and reminders to bring it on subsequent visits will be mentioned. The principal investigator will ensure that each patient used at least 75% and not more than 125% of the study drug over the course of the study period. The drug accountability i.e., receipt, dispensing, and return of the drug) will be performed either by the principal investigator or his designee. The assessment of the primary endpoint will be based on the clinical scoring conducted on a weekly basis till the end of the study.
Clinical Evaluation The clinical parameters such as plaque index (PI) and papillary bleeding index (PBI) will be evaluated for all the patients at the appropriate follow-up intervals. The parameters will be evaluated by two independent examiners. The adverse events, if any with the administration of TQ gel will be monitored and it would be graded as per the intensity as mild, moderate, and severe.
Discontinuation of Treatment In case of adverse events with the use of the study drug, the patients would be withdrawn from therapy or clinical assessment. Also, when the patients suffer from significant illness or undergo surgery during the course of the study, they would be withdrawn from the trial. The non-compliant patients who did not adhere to the study protocol or for other justifiable reasons were withdrawn from the current clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group I (SRP and TQ gel) | Experimental | Biological: 5% thymoquinone (TQ) gelIn 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 |
| Group II (SRP and Placebo) | Placebo comparator | Biological: SRP and placeboIn 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 III (Only SRP and one stage prophylaxis) | Active comparator | Procedure: Only SRP-one stage prophylaxisThe Group III patients will be subjected to one-stage oral prophylaxis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Patient diagnosed with gingivitis (Probing<3mm with bleeding on probing ≥10% of sites) (Trombelli, Farina et al. 2018)
Key exclusion criteria (6 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% thymoquinone (TQ) gelMode 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. | Biological | Group I (SRP and TQ gel) |
| SRP and placeboIn 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 | Group II (SRP and Placebo) |
| Only SRP-one stage prophylaxisThe Group III patients will be subjected to one-stage oral prophylaxis. | Procedure or surgery | Group III (Only SRP and one stage prophylaxis) |
Primary outcome
Plaque index
Time frame: 2 weeks
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.
Papillary bleeding index
Time frame: 2 weeks
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 secondary outcomes
Number of participants with drug related adverse events
Time frame: Duration of the clinical trial
Number of participants non compliant/withdraw from the study
Time frame: Duration of the clinical trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- BackgroundAbou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad AlMehmadi principal investigator
King Abdul Aziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 5% thymoquinone (TQ) gel and Only SRP-one stage prophylaxis in people with Gingivitis, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Almehmadi (+966561111056, ahmadkau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.