Chronic PeriodontitisPhase 2NCT05005767
Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis
A Phase 2 study testing scaling and root planing and Frankincense extract gel natural herbal product in people with Chronic Periodontitis, run by Tanta University at 1 site in Egypt.
Trial summary
This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- scaling and root planing and Frankincense extract gel natural herbal product
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to Mar 2022
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy patients were selected
- patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- Patients should demonstrate their ability to maintain good oral hygiene
Who cannot join
- Smokers and pregnant patients.
- Medically compromised patients and systemic conditions precluding periodontal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Adjunctive Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis: Clinical and Microbiological Study.
This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.
Read the detailed description
: twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after treatment.
- Conditions
- Chronic Periodontitis
- Being tested
- scaling and root planing, Frankincense extract gel natural herbal product
- Keywords
- chronic periodontitis., Frankincense, non surgical treatment
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
will receive scaling and root planing only
Frankincense extract gel natural herbal productProcedure or surgery
Also called Scaling and root planing
will receive Scaling and root planing then. Subgingival application of Frankincense extract gel
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | ten patients with sites suffering from mild chronic periodontitis sites will be treated with scaling and root planing (SRP) only Receives: Procedure: scaling and root planing |
| test group | Active comparator | Ten patients with sites suffering from mild chronic periodontitis. sites will be treated with scaling and root planing (SRP) and subgingival application of Frankincense extract gel Receives: Procedure: scaling and root planing; Procedure: Frankincense extract gel natural herbal product |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
probing pocket depth will be recorded at baseline, at site that will be treated
Measured: baseline
probing pocket depth
probing pocket depth will be recorded at 1 month at the site to be treated
Measured: 1 month
probing pocket depth
probing pocket depth will be recorded at 3 month at the site to be treated
Measured: 3 month
clinical attachment level
clinical attachment level will be recorded at baseline,
Measured: baseline
clinical attachment level
clinical attachment level will be recorded at , 1 month at the site to be treated
Measured: 1 month
clinical attachment level
clinical attachment level will be recorded at 3 months at the site to be treated
Measured: 3 month
bleeding on probing
bleeding on probingwill be recorded at baseline, at the site to be treated
Measured: baseline
bleeding on probing
bleeding on probingwill be recorded at 1, month at the site to be treated
Measured: 1 month
bleeding on probing
bleeding on probingwill be recorded at 3 months at the site to be treated
Measured: 3 month
PCR for Porphyromonas gingivalis count
PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated
Measured: baseline
PCR for Porphyromonas gingivalis count
PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated
Measured: 1 month
PCR for Porphyromonas gingivalis count
PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Apr 2021
- Primary completionNov 2021 (estimated)
- Study completionMar 2022 (estimated)
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- twenty patients will be randomly be selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ahmed Yousef, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005767
- Sponsor's protocol ID
- 2D
- Status last verified
- Aug 2021
- First submitted
- 31 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis: Clinical and Microbiological Study.
- ClinicalTrials.gov ID
- NCT05005767
- Acronym / sponsor ID
- 2D
- Conditions
- Chronic Periodontitis
- Keywords
- chronic periodontitis., Frankincense, non surgical treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 16 Aug 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.
This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.
Detailed description
: twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- twenty patients will be randomly be selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days.
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Procedure: scaling and root planingten patients with sites suffering from mild chronic periodontitis sites will be treated with scaling and root planing (SRP) only |
| test group | Active comparator | Procedure: scaling and root planing, Procedure: Frankincense extract gel natural herbal productTen patients with sites suffering from mild chronic periodontitis. sites will be treated with scaling and root planing (SRP) and subgingival application of Frankincense extract gel |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemically healthy patients were selected
- patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- Patients should demonstrate their ability to maintain good oral hygiene
Key exclusion criteria (2 listed)
- Smokers and pregnant patients.
- Medically compromised patients and systemic conditions precluding periodontal surgery.
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 |
|---|---|---|
| scaling and root planingwill receive scaling and root planing only | Procedure or surgery | Placebo group, test group |
| Frankincense extract gel natural herbal productAlso: Scaling and root planingwill receive Scaling and root planing then. Subgingival application of Frankincense extract gel | Procedure or surgery | test group |
Primary outcome
probing pocket depth
Time frame: baseline
probing pocket depth will be recorded at baseline, at site that will be treated
probing pocket depth
Time frame: 1 month
probing pocket depth will be recorded at 1 month at the site to be treated
probing pocket depth
Time frame: 3 month
probing pocket depth will be recorded at 3 month at the site to be treated
clinical attachment level
Time frame: baseline
clinical attachment level will be recorded at baseline,
clinical attachment level
Time frame: 1 month
clinical attachment level will be recorded at , 1 month at the site to be treated
clinical attachment level
Time frame: 3 month
clinical attachment level will be recorded at 3 months at the site to be treated
bleeding on probing
Time frame: baseline
bleeding on probingwill be recorded at baseline, at the site to be treated
bleeding on probing
Time frame: 1 month
bleeding on probingwill be recorded at 1, month at the site to be treated
bleeding on probing
Time frame: 3 month
bleeding on probingwill be recorded at 3 months at the site to be treated
PCR for Porphyromonas gingivalis count
Time frame: baseline
PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated
PCR for Porphyromonas gingivalis count
Time frame: 1 month
PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated
PCR for Porphyromonas gingivalis count
Time frame: 3 month
PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- 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.
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 Phase 2 study testing scaling and root planing and Frankincense extract gel natural herbal product in people with Chronic Periodontitis, run by Tanta University at 1 site 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 2 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 16 Aug 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 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
probing pocket depth (time frame: baseline). The study lists 12 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 16 Aug 2021.