Chronic PeriodontitisLLLvsAgelNCT06805292
Evaluation of Acacia Catechu and Low-Level Laser in the Treatmentof Stage II Periodontitis
A study testing Acacia catechu, Low Level Laser Therapy and phase 1 therapy chronic periodontitis in people with Chronic Periodontitis, run by Faculty of Dental Medicine for Girls at 2 sites in Egypt.
Trial summary
Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Acacia catechu, Low Level Laser Therapy and phase 1 therapy chronic periodontitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Sep 2022to 20 Nov 2024
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Motivated patient with good oral hygiene.
- Age ranges from (30-50) years.
- Free from any systemic disease according to the Cornell Medical Index (16).
Who cannot join
- Patients who received periodontal treatment over the 12 months preceding the study.
- Patients who consumed antibiotics or anti-inflammatory drugs within the last 3 months.
- Previous or current radiation or immunosuppressive therapies.
- Pregnant \& lactating women.
- Patient with orthodontic appliances. Or having partial dentures.
- Patient with parafunctional habits.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Acacia Catechu and Low-Level Laser in the Treatment of Stage II Periodontitis
Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis.
Read the detailed description
- Assess the effectiveness of A. catechu gel (local delivery) adjunctive to non surgical therapy in the treatment of stage chronic periodontitis. Clinical and biochemical evaluation.
- Compare the effectiveness of A. catechu gel (local delivery) and low-level laser adjunctive to non-surgical therapy in the treatment of stage chronic periodontitis.
Clinical and biochemical evaluation.
- Conditions
- Chronic Periodontitis
- Being tested
- Acacia catechu, Low Level Laser Therapy, phase 1 therapy chronic periodontitis, local drug delivary acacia +LLL
- Keywords
- Chronic periodontitis, Herbal Medicine, Low Level Laser Therapy, Adjunctive therapy, Acacia catechu
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia catechuOther
Also called acaia catech gel, black catechu (trade name ), black cutch, cutch tree,
local delivery of acacia catechu gel in patient with chronic periodontitis stage 2
Low Level Laser TherapyOther
Also called Biomodulation
low-level laser as an adjunctive therapy in patient with chronic periodontitis stage 2
phase 1 therapy chronic periodontitisOther
Also called phase 1 therapy (scalling +root planning)
patient with chronic periodontitis stage 2 will go for phase one therapy only
local drug delivary acacia +LLLOther
Also called LLL +acacia catehu gel
pateient with chronic periodontitis treated with LLL +acacia catehu gel
| Study group | Role | What they receive |
|---|---|---|
| Control Groupe | Active comparator | treated with non-surgical periodontal therapy and serves as a control group. Receives: Other: phase 1 therapy chronic periodontitis |
| Test: Acacia gel group | Active comparator | using A. catechu gel adjunctive to non-surgical periodontal therapy Receives: Other: Acacia catechu |
| Test: laser group | Active comparator | Group III: using low-level laser adjunctive to non-surgical periodontal therapy. Receives: Other: Low Level Laser Therapy |
| Test: Acacia gel +laser group | Active comparator | Group IV: using A. catechu gel with low-level laser adjunctive to non-surgical periodontal therapy. Receives: Other: Acacia catechu; Other: Low Level Laser Therapy; Other: phase 1 therapy chronic periodontitis; Other: local drug delivary acacia +LLL |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory biomarker
Measuring Interleukin 1 beta level
Measured: 0 and 6 month evaluation
Antioxidant biomarker
measuring total antioxidant capacity.
Measured: 0 and 6 month evaluation
Secondary outcomes (3)
gingival index
clinical evaluation of GI
score from (0 to 3) 0 = normal is the best value. 3 = diseesed (the worst value).
0=Normal gingiva.
- = mild inflammation, a slight change in color, slight edema, no bleeding on probing.
- = moderate inflammation, redness, edema, and glazing; bleeding on probing.
- = severe inflammation, marked redness and edema, ulceration, and the tendency to spontaneous bleeding.
Measured: 0,1,3,6 month evaluation
clinical attachment level or loss
- Clinical Attachment Level (CAL) or loss: Clinical attachment level was measured from the cementoenamel junction to the base of the pocket using a University of Michigan probe with the University of North Carolina periodontal probe (UNC15) around each tooth.
- measurement unite by millimetre
- zero clinical attachment level means no periodontitis
- clinical attachment loss is a critical parameter differentiated betwwn gingivitis and periodontitis
- the less the number, the better the case improvement.
- cal of 2 mm is better than cal of 4 mm.
Measured: 0,1,3,6 month evaluation
plaque index
evaluation of PI score from (0-3) 0 is the best value; 3 is the worst.
0=No plaque is visible, even when a probe is used.
- = Some plaque is visible only when a probe is used to skim the tooth surface.
- = A visible amount of plaque can be seen without a probe.
- = abudant amount of plaque at gingival margin, interdental spaces filled with plaque.
Measured: 0,1,3,6 month evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start20 Sep 2022
- Primary completion19 May 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mona Monsour, Faculty of Dental Medicine for Girls
- Investigators
- Abeer Gawish, professor, Study director, Al-Azhar Universitymostafa hegazy, professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805292
- Sponsor's protocol ID
- OMPDR-108-1J
- Acronym
- LLLvsAgel
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 3 Feb 2025
- 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acacia Catechu and Low-Level Laser in the Treatment of Stage II Periodontitis
- ClinicalTrials.gov ID
- NCT06805292
- Acronym / sponsor ID
- LLLvsAgel / OMPDR-108-1J
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic periodontitis, Herbal Medicine, Low Level Laser Therapy, Adjunctive therapy, Acacia catechu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 3 Feb 2025 (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.
Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis.
Detailed description
- Assess the effectiveness of A. catechu gel (local delivery) adjunctive to non surgical therapy in the treatment of stage chronic periodontitis. Clinical and biochemical evaluation.
- Compare the effectiveness of A. catechu gel (local delivery) and low-level laser adjunctive to non-surgical therapy in the treatment of stage chronic periodontitis.
Clinical and biochemical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Groupe | Active comparator | Other: phase 1 therapy chronic periodontitistreated with non-surgical periodontal therapy and serves as a control group. |
| Test: Acacia gel group | Active comparator | Other: Acacia catechuusing A. catechu gel adjunctive to non-surgical periodontal therapy |
| Test: laser group | Active comparator | Other: Low Level Laser TherapyGroup III: using low-level laser adjunctive to non-surgical periodontal therapy. |
| Test: Acacia gel +laser group | Active comparator | Other: Acacia catechu, Other: Low Level Laser Therapy, Other: phase 1 therapy chronic periodontitis, Other: local drug delivary acacia +LLLGroup IV: using A. catechu gel with low-level laser adjunctive to non-surgical periodontal therapy. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Motivated patient with good oral hygiene.
- Age ranges from (30-50) years.
- Free from any systemic disease according to the Cornell Medical Index (16).
Key exclusion criteria (6 listed)
- Patients who received periodontal treatment over the 12 months preceding the study.
- Patients who consumed antibiotics or anti-inflammatory drugs within the last 3 months.
- Previous or current radiation or immunosuppressive therapies.
- Pregnant \& lactating women.
- Patient with orthodontic appliances. Or having partial dentures.
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 catechuAlso: acaia catech gel, black catechu (trade name ), black cutch, cutch tree,local delivery of acacia catechu gel in patient with chronic periodontitis stage 2 | Other | Test: Acacia gel +laser group, Test: Acacia gel group |
| Low Level Laser TherapyAlso: Biomodulationlow-level laser as an adjunctive therapy in patient with chronic periodontitis stage 2 | Other | Test: Acacia gel +laser group, Test: laser group |
| phase 1 therapy chronic periodontitisAlso: phase 1 therapy (scalling +root planning)patient with chronic periodontitis stage 2 will go for phase one therapy only | Other | Control Groupe, Test: Acacia gel +laser group |
| local drug delivary acacia +LLLAlso: LLL +acacia catehu gelpateient with chronic periodontitis treated with LLL +acacia catehu gel | Other | Test: Acacia gel +laser group |
Primary outcome
inflammatory biomarker
Time frame: 0 and 6 month evaluation
Measuring Interleukin 1 beta level
Antioxidant biomarker
Time frame: 0 and 6 month evaluation
measuring total antioxidant capacity.
3 secondary outcomes
gingival index
Time frame: 0,1,3,6 month evaluation
clinical attachment level or loss
Time frame: 0,1,3,6 month evaluation
plaque index
Time frame: 0,1,3,6 month evaluation
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 3 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Abeer Gawish, professor study director
Al-Azhar University
mostafa hegazy, professor study director
Al-Azhar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acacia catechu, Low Level Laser Therapy and phase 1 therapy chronic periodontitis in people with Chronic Periodontitis, run by Faculty of Dental Medicine for Girls at 2 sites in Egypt.
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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
inflammatory biomarker (time frame: 0 and 6 month evaluation). 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?
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 3 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.