GingivitisNCT04723732
Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash
A study testing Myrrh mouthwash, Chlorhexidine mouthwash and Normal saline in people with Gingivitis and Dental Plaque, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little research has been carried out to determine its true clinical significance on periodontal health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Myrrh mouthwash, Chlorhexidine mouthwash and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Aug 2017to 15 Dec 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good periodontal health;
- dentition of ≥20 teeth and a minimum of 5 teeth per quadrant;
- the absence of any systemic illness;
- no history of oral prophylaxis in the past 6 months;
- no relevant medical history that might compromise normal oral hygiene practice.
Who cannot join
- pocket depth >3 mm
- severe misalignment of teeth;
- the presence of orthodontic appliances;
- intake of antibiotic and/or anti-inflammatory medications within the past 6 months;
- use of tobacco;
- inability of comply with the study's appointment schedule;
- pregnant or breast-feeding mothers.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz University
Jeddah, Mecca Region, 21589
About this study
Official title: A Clinical Study Comparing the Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash With Chlorhexidine Mouthwash in a 14-Day Experimental Gingivitis Model
Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little research has been carried out to determine its true clinical significance on periodontal health. The purpose of this study is to evaluate and compare the efficacy of 1% myrrh mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.
Read the detailed description
This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on probing < 10%). We will include all eligible patients seeking dental treatment at the center after gaining a written informed consent. After the initial dental screening and a session of professional teeth cleaning procedures, participants will be instructed to refrain from regular oral hygiene practices for 2 weeks to develop experimental gingivitis. Participants will then be randomly allocated to one of the three treatment groups [1:1:1] using a simple randomization method (i.e. computer-generated random numbers). They will be instructed to continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash twice daily for 1 minute. Treatment effect will be evaluated by comparing the baseline (day 0) and post-intervention (day 14) values of all clinical parameters (modified gingival index, plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Myrrh mouthwash, Chlorhexidine mouthwash, Normal saline
- Keywords
- gingivitis, herbal, myrrh, myrrha, antigingivitis, antiplaque, IL-1, dental plaque
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myrrh mouthwashDrug
Also called Commiphora myrrha mouthwash
1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.
Chlorhexidine mouthwashDrug
Also called Chlorhexidine gluconate mouthwash, Avalon Avohex mouthwash
0.2% mouthwash solution of chlorhexidine gluconate.
Normal salineDrug
Also called Sodium Chloride solution
0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)
| Study group | Role | What they receive |
|---|---|---|
| Myrrh mouthwash | Experimental | 1% mouthwash of Commiphora myrrha made from resin extract. Participants will use 10 ml of the mouthwash twice daily for 14 days. Receives: Drug: Myrrh mouthwash |
| Chlorhexidine Mouthwash | Active comparator | Commercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh). Participants will use 10 ml of the mouthwash twice daily for 14 days. Receives: Drug: Chlorhexidine mouthwash |
| Normal saline | Placebo comparator | Commercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah). Participants will use 10 ml of the mouthwash twice daily for 14 days. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
IL-1β is an important mediator of the inflammatory response. Elevated IL-1β levels have been reported in a number of infectious disease conditions and in noninfectious inflammatory conditions. Human IL-1β ELISA kit by BioVendor was utilized to determine the IL-1β level. Preparation of reagents, execution of test protocol, and calculation of results were done adhering to the manufacturer's Product Data Sheet enclosed with the kit. The absorbance of each strip was read on a spectro-photometer at 450 nm wave length.
Measured: Baseline and Day 14
Secondary outcomes (3)
Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14
The MGI is a noninvasive visual assessment tool to assess the severity of gingivitis over time. It uses a rating score between 0 (normal gingiva) and 3 (severe inflammation with tendency to spontaneous bleeding). Change = (Day 14 Score - Baseline Score)
Measured: Baseline, Day 7, and Day 14
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14
The PI is a validated assessment tool based on recording of the presence of soft debris and mineralized deposits on all 4 surfaces of all teeth. It uses a rating score between 0 (no plaque) and 1 (plaque present at gingival margin). Change = (Day 14 Score - Baseline Score)
Measured: Baseline, Day 7, and Day 14
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14
The GBI is a reliable indicator of gingival inflammation and periodontal stability. It uses gentle probing of the orifice of the gingival sulcus. The bleeding on probing (BOP) was assessed using a standardized periodontal probe with a 0.6 mm tip and 1 mm marking. A trained examiner measured BOP applying probing forces not exceeding 0.25 N (25 g). A positive finding was recorded if bleeding occured within 10 seconds.
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start15 Aug 2017
- Primary completion15 Aug 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, talal zahid, King Abdulaziz University
- Investigators
- Talal Zahid, M.S, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723732
- Sponsor's protocol ID
- 058-15
- Status last verified
- Jan 2021
- First submitted
- 9 Nov 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing the Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash With Chlorhexidine Mouthwash in a 14-Day Experimental Gingivitis Model
- ClinicalTrials.gov ID
- NCT04723732
- Acronym / sponsor ID
- 058-15
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- gingivitis, herbal, myrrh, myrrha, antigingivitis, antiplaque, IL-1, dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 26 Jan 2021 (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.
Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little research has been carried out to determine its true clinical significance on periodontal health. The purpose of this study is to evaluate and compare the efficacy of 1% myrrh mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.
Detailed description
This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on probing < 10%). We will include all eligible patients seeking dental treatment at the center after gaining a written informed consent. After the initial dental screening and a session of professional teeth cleaning procedures, participants will be instructed to refrain from regular oral hygiene practices for 2 weeks to develop experimental gingivitis. Participants will then be randomly allocated to one of the three treatment groups [1:1:1] using a simple randomization method (i.e. computer-generated random numbers). They will be instructed to continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash twice daily for 1 minute. Treatment effect will be evaluated by comparing the baseline (day 0) and post-intervention (day 14) values of all clinical parameters (modified gingival index, plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myrrh mouthwash | Experimental | Drug: Myrrh mouthwash1% mouthwash of Commiphora myrrha made from resin extract. Participants will use 10 ml of the mouthwash twice daily for 14 days. |
| Chlorhexidine Mouthwash | Active comparator | Drug: Chlorhexidine mouthwashCommercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh). Participants will use 10 ml of the mouthwash twice daily for 14 days. |
| Normal saline | Placebo comparator | Drug: Normal salineCommercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah). Participants will use 10 ml of the mouthwash twice daily for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- good periodontal health;
- dentition of ≥20 teeth and a minimum of 5 teeth per quadrant;
- the absence of any systemic illness;
- no history of oral prophylaxis in the past 6 months;
- no relevant medical history that might compromise normal oral hygiene practice.
Key exclusion criteria (7 listed)
- pocket depth >3 mm
- severe misalignment of teeth;
- the presence of orthodontic appliances;
- intake of antibiotic and/or anti-inflammatory medications within the past 6 months;
- use of tobacco;
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 |
|---|---|---|
| Myrrh mouthwashAlso: Commiphora myrrha mouthwash1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract. | Drug | Myrrh mouthwash |
| Chlorhexidine mouthwashAlso: Chlorhexidine gluconate mouthwash, Avalon Avohex mouthwash0.2% mouthwash solution of chlorhexidine gluconate. | Drug | Chlorhexidine Mouthwash |
| Normal salineAlso: Sodium Chloride solution0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride) | Drug | Normal saline |
Primary outcome
Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
Time frame: Baseline and Day 14
IL-1β is an important mediator of the inflammatory response. Elevated IL-1β levels have been reported in a number of infectious disease conditions and in noninfectious inflammatory conditions. Human IL-1β ELISA kit by BioVendor was utilized to determine the IL-1β level. Preparation of reagents, execution of test protocol, and calculation of results were done adhering to the manufacturer's Product Data Sheet enclosed with the kit. The absorbance of each strip was read on a spectro-photometer at 450 nm wave length.
3 secondary outcomes
Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14
Time frame: Baseline, Day 7, and Day 14
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14
Time frame: Baseline, Day 7, and Day 14
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14
Time frame: Baseline and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Talal Zahid, M.S principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myrrh mouthwash, Chlorhexidine mouthwash and Normal saline in people with Gingivitis and Dental Plaque, 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14 (time frame: Baseline and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2021.