Gingival and Periodontal DiseaseNCT07840131
Anti-microbial Effect of Acacia Arabica Extract on Gingival and Periodontal Health of Dental Patients
A study testing Acacia arabica Mouth Rinse and acacia arabica paste in people with Gingival and Periodontal Disease, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
This randomized clinical pilot study evaluated the short-term effects of Acacia arabica mouth rinse and paste as adjuncts to conventional oral hygiene in adults with plaque-induced gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Gingival and Periodontal Disease
- What is being tested?
- Acacia arabica Mouth Rinse and acacia arabica paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2025to 30 Dec 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-42 years.
- Diagnosis of plaque-induced gingivitis.
- Presence of gingival inflammation without clinical attachment loss or -radiographic evidence of alveolar bone loss.
- Presence of a minimum of 15 natural teeth per arch.
- Willingness to participate and provide written informed consent.
Who cannot join
- Systemic diseases or medical conditions that may affect periodontal health.
- Recent use of antibiotics or anti-inflammatory medications.
- Presence of fixed orthodontic appliances/wires.
- Current smoking.
- Pregnancy or lactation.
- Known allergy or hypersensitivity to herbal products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Acacia Arabica Mouth Rinse and Paste on Plaque-induced Gingivitis
This randomized clinical pilot study evaluated the short-term effects of Acacia arabica mouth rinse and paste as adjuncts to conventional oral hygiene in adults with plaque-induced gingivitis. Thirty systemically healthy participants aged 18-42 years were randomly allocated into three groups: a control group receiving conventional oral hygiene measures, an Acacia arabica mouth rinse group, and an Acacia arabica paste group. All participants received professional plaque removal and standardized oral hygiene instructions at baseline. Participants in the intervention groups additionally used either the Acacia arabica mouth rinse or paste twice daily for four weeks. Clinical assessments were performed at baseline, 2 weeks, and 4 weeks. The study evaluated changes in plaque index, gingival index, bleeding on probing, and salivary pH. The study aimed to determine whether Acacia arabica formulations could provide additional short-term benefits in plaque and gingival inflammation control compared with conventional oral hygiene measures alone.
- Conditions
- Gingival and Periodontal Disease
- Being tested
- Acacia arabica Mouth Rinse, acacia arabica paste
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia arabica Mouth RinseOther
the rinse as 1 g extract/10 mL distilled water
acacia arabica pasteOther
a pea-sized amount of Acacia arabica paste (Gumtone® gel)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Participants received professional plaque removal at baseline and standardized oral hygiene instructions, including the modified Bass brushing technique. Participants were instructed to brush twice daily using a regular fluoridated toothpaste and received no Acacia arabica intervention during the 4-week study period. |
| Acacia arabica Mouth Rinse | Experimental | Participants received professional plaque removal and standardized oral hygiene instructions at baseline. In addition, participants used 10 mL of Acacia arabica mouth rinse, prepared at a concentration of 1 g of extract per 10 mL of distilled water, twice daily after toothbrushing for 4 weeks. Participants were instructed to swish the solution for 1 minute, retain it intraorally for an additional 2 minutes, and then expectorate. Receives: Other: Acacia arabica Mouth Rinse |
| Acacia arabica Paste | Experimental | Participants received professional plaque removal and standardized oral hygiene instructions at baseline. In addition, participants applied a pea-sized amount of Acacia arabica paste (Gumtone® gel) to the gingiva twice daily after toothbrushing for 4 weeks. The paste was gently massaged into the gingiva for approximately 2 minutes and subsequently removed using gauze. Receives: Other: acacia arabica paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Index (GI)
Gingival inflammation was assessed using the Gingival Index at baseline, 2 weeks, and 4 weeks. The index was used to evaluate changes in the severity of gingival inflammation during the intervention period. Lower scores indicate less gingival inflammation and better gingival health.
Measured: Baseline, 2 weeks, and 4 weeks
Change in Plaque Index (PI)
Plaque accumulation was assessed using the Plaque Index at baseline, 2 weeks, and 4 weeks. The index was used to quantify changes in dental plaque accumulation during the intervention period. Lower scores indicate less plaque accumulation and better plaque control.
Measured: Baseline, 2 weeks, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Jan 2025
- Primary completion31 Aug 2025
- Study completion30 Dec 2025
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 Gingival and Periodontal DiseaseStudies 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
- Model description
- Participants were randomly allocated in a 1:1:1 ratio to one of three parallel groups: a control group receiving professional plaque removal and standardized oral hygiene instructions alone, an Acacia arabica mouth-rinse group receiving the same conventional oral hygiene measures plus Acacia arabica mouth rinse twice daily, or an Acacia arabica paste group receiving the same conventional oral hygiene measures plus Acacia arabica paste twice daily. Participants were followed for four weeks, with clinical assessments performed at baseline, 2 weeks, and 4 weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Alsahafi, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840131
- Sponsor's protocol ID
- (HAPO-02-K-012-2024-10-2310
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be publicly shared due to participant confidentiality and institutional ethical considerations. De-identified data supporting the findings may be made available from the corresponding investigator upon reasonable request and subject to institutional and ethical approval.
Publications
Pradeep AR, Happy D, Garg G. Short-term clinical effects of commercially available gel containing Acacia arabica: a randomized controlled clinical trial. Aust Dent J. 2010 Mar;55(1):65-9. doi: 10.1111/j.1834-7819.2009.01180.x.
PubMed 20415914
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Acacia Arabica Mouth Rinse and Paste on Plaque-induced Gingivitis
- ClinicalTrials.gov ID
- NCT07840131
- Acronym / sponsor ID
- (HAPO-02-K-012-2024-10-2310
- Conditions
- Gingival and Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Sep 2026 (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.
This randomized clinical pilot study evaluated the short-term effects of Acacia arabica mouth rinse and paste as adjuncts to conventional oral hygiene in adults with plaque-induced gingivitis. Thirty systemically healthy participants aged 18-42 years were randomly allocated into three groups: a control group receiving conventional oral hygiene measures, an Acacia arabica mouth rinse group, and an Acacia arabica paste group. All participants received professional plaque removal and standardized oral hygiene instructions at baseline. Participants in the intervention groups additionally used either the Acacia arabica mouth rinse or paste twice daily for four weeks. Clinical assessments were performed at baseline, 2 weeks, and 4 weeks. The study evaluated changes in plaque index, gingival index, bleeding on probing, and salivary pH. The study aimed to determine whether Acacia arabica formulations could provide additional short-term benefits in plaque and gingival inflammation control compared with conventional oral hygiene measures alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly allocated in a 1:1:1 ratio to one of three parallel groups: a control group receiving professional plaque removal and standardized oral hygiene instructions alone, an Acacia arabica mouth-rinse group receiving the same conventional oral hygiene measures plus Acacia arabica mouth rinse twice daily, or an Acacia arabica paste group receiving the same conventional oral hygiene measures plus Acacia arabica paste twice daily. Participants were followed for four weeks, with clinical assessments performed at baseline, 2 weeks, and 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Participants received professional plaque removal at baseline and standardized oral hygiene instructions, including the modified Bass brushing technique. Participants were instructed to brush twice daily using a regular fluoridated toothpaste and received no Acacia arabica intervention during the 4-week study period. |
| Acacia arabica Mouth Rinse | Experimental | Other: Acacia arabica Mouth RinseParticipants received professional plaque removal and standardized oral hygiene instructions at baseline. In addition, participants used 10 mL of Acacia arabica mouth rinse, prepared at a concentration of 1 g of extract per 10 mL of distilled water, twice daily after toothbrushing for 4 weeks. Participants were instructed to swish the solution for 1 minute, retain it intraorally for an additional 2 minutes, and then expectorate. |
| Acacia arabica Paste | Experimental | Other: acacia arabica pasteParticipants received professional plaque removal and standardized oral hygiene instructions at baseline. In addition, participants applied a pea-sized amount of Acacia arabica paste (Gumtone® gel) to the gingiva twice daily after toothbrushing for 4 weeks. The paste was gently massaged into the gingiva for approximately 2 minutes and subsequently removed using gauze. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-42 years.
- Diagnosis of plaque-induced gingivitis.
- Presence of gingival inflammation without clinical attachment loss or -radiographic evidence of alveolar bone loss.
- Presence of a minimum of 15 natural teeth per arch.
- Willingness to participate and provide written informed consent.
Key exclusion criteria (6 listed)
- Systemic diseases or medical conditions that may affect periodontal health.
- Recent use of antibiotics or anti-inflammatory medications.
- Presence of fixed orthodontic appliances/wires.
- Current smoking.
- Pregnancy or lactation.
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 |
|---|---|---|
| Acacia arabica Mouth Rinsethe rinse as 1 g extract/10 mL distilled water | Other | Acacia arabica Mouth Rinse |
| acacia arabica pastea pea-sized amount of Acacia arabica paste (Gumtone® gel) | Other | Acacia arabica Paste |
Primary outcome
Change in Gingival Index (GI)
Time frame: Baseline, 2 weeks, and 4 weeks
Gingival inflammation was assessed using the Gingival Index at baseline, 2 weeks, and 4 weeks. The index was used to evaluate changes in the severity of gingival inflammation during the intervention period. Lower scores indicate less gingival inflammation and better gingival health.
Change in Plaque Index (PI)
Time frame: Baseline, 2 weeks, and 4 weeks
Plaque accumulation was assessed using the Plaque Index at baseline, 2 weeks, and 4 weeks. The index was used to quantify changes in dental plaque accumulation during the intervention period. Lower scores indicate less plaque accumulation and better plaque control.
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 24 Sep 2026.
- Background: PubMed 20415914Pradeep AR, Happy D, Garg G. Short-term clinical effects of commercially available gel containing Acacia arabica: a randomized controlled clinical trial. Aust Dent J. 2010 Mar;55(1):65-9. doi: 10.1111/j.1834-7819.2009.01180.x.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be publicly shared due to participant confidentiality and institutional ethical considerations. De-identified data supporting the findings may be made available from the corresponding investigator upon reasonable request and subject to institutional and ethical approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acacia arabica Mouth Rinse and acacia arabica paste in people with Gingival and Periodontal Disease, run by Umm Al-Qura 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 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: finished, as of the sponsor's last update on 24 Sep 2026. 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. 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 in Gingival Index (GI) (time frame: Baseline, 2 weeks, and 4 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 NCT07840131, 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 24 Sep 2026.