PeriodontitisEarly Phase 1NCT05125718
Clinical and Metagenomic Investigation of Antimicrobial Peptide Gel in Periodontal Treatment.
A Early Phase 1 study testing 0.85% synthetic antimicrobial peptide TAPS-18 and 0.9% normal saline in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.
Trial summary
Background and objective(s): Periodontitis is initiated by a dysbiotic host-microbe relationship. Standard periodontal treatment involves oral hygiene education, mechanical debridement and periodic follow-ups with the aims of pocket closure and maintaining a symbiotic microbial community. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- 0.85% synthetic antimicrobial peptide TAPS-18 and 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2021to 30 Apr 2021
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Subject diagnosed with generalised periodontitis Stage III of any grade (Caton et al., 2018).
- Age ≥21 years old.
- Subject is in good general health without any remarkable past history of disease except for well controlled diabetes (HbA1c ≤6.5%) (Clinical practice guidelines on management of type 2 diabetes mellitus., 2020).
- Presence of at least 20 teeth.
- Presence of at least 2 non-adjacent sites located in contralateral quadrant with interproximal probing pocket depth (PPD) ≥6mm.
Who cannot join
- • Received subgingival scaling in the previous 6 months.
- Use of antibiotic in the past 6 months.
- Taking steroidal and non-steroidal anti-inflammatory agents on a daily basis.
- Medical condition requiring antibiotic prophylaxis.
- Pregnancy or lactating.
- Smoking ≥10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
faculty of dentistry, University of Malaya
Kuala Lumpur, 50603
About this study
Official title: Clinical and Metagenomic Investigation of Locally Delivered Synthetic Antimicrobial Peptide Gel in Non-surgical Periodontal Treatment: a Pilot Study.
Background and objective(s): Periodontitis is initiated by a dysbiotic host-microbe relationship. Standard periodontal treatment involves oral hygiene education, mechanical debridement and periodic follow-ups with the aims of pocket closure and maintaining a symbiotic microbial community. Nonetheless, this therapy alone may fail due to the limitations of mechanical instrumentation. The use of antimicrobial in combination to subgingival debridement has been proposed for initial and recurrent periodontitis to enhance the effectiveness of mechanical instrumentation. Antimicrobial peptide (AMP) comprised of a wide range of peptide, was found naturally in various life forms or manufactured as a synthetic compound. This study was conducted to evaluate the use of AMP as an adjunct to non-surgical periodontal treatment in terms of clinical and microbiological outcomes.
Hypothesis
- There are changes in clinical periodontal parameters and subgingival microbial profile following treatment with locally delivered synthetic AMP.
Read the detailed description
study design: This was a split-mouth randomised pilot study of a 3-months follow-up.
Sample size calculation: The sample size was calculated using G*Power software version 3.1.9.4 (Franz Faul, Universitat Kiel, Germany). Estimation of sample size was based on the mean and standard deviation of CAL between the test and control group of previous publication (Singh et al., 2018). Four samples in each group (test and control) were required to achieve 80% power at a significant level of 5%.
Randomisation: The random allocation sequence was generated by another person who was not directly involved in the study using a Research Randomizer tools (https://www.randomizer.org/). Periodontal sites of each patient were randomised at a split mouth level (left or right halves of the dentition) to one of the two treatment groups. Allocated treatments were inserted into an opaque envelop. Treatment allocation was concealed from the clinician and only revealed once subgingival debridement was completed.
intervention: At baseline, clinical measurement was recorded and target sites (sites with PPD ≥6mm) were identified. subgingival plaque were collected at target sites. The same clinician performed full mouth scaling and subgingival debridement, coupled with standardised oral hygiene instruction for all subjects. Upon the completion of treatment, second clinician applied the treatments according to the randomisation.
- Test group: Subgingival instrumentation followed by Antimcrobial peptide gel (AMP) application in all target sites.
- Control group: Subgingival instrumentation and normal saline irrigation in all target sites.
Test and control intervention will be repeated for another 2 applications at an interval of 3 days. Subjects were re-examined and plaque sampling will be repeated at 6 weeks and 12 weeks.
statistical analysis: Clinical parameters were reported as mean and standard deviation. P-value <0.05 was considered statistically significant. intergroup and intragroup comparison of mean bleeding score, pocket depth, clinical attachment level will be conducted using SPSS software. For the metagenomic data, alpha and beta diversity were computed using QIIME 2. The difference in the relative abundance of individual genus over time will be analysed.
- Conditions
- Periodontitis
- Being tested
- 0.85% synthetic antimicrobial peptide TAPS-18, 0.9% normal saline
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.85% synthetic antimicrobial peptide TAPS-18Drug
Also called antimicrobial peptide gel Ace Helper™
commercially available synthetic antimicrobial peptide gel for periodontal disease treatment
0.9% normal salineDrug
Also called RinsCap Normal Saline Sodium Chloride Irrigation Solution
commercially available normal saline Sodium Chloride irrigation solution
| Study group | Role | What they receive |
|---|---|---|
| test group (antimicrobial peptide) | Experimental | Half of the dentition will receive scaling and root surface debridement within a week followed by the application of antimicrobial peptide gel Ace Helper™ into the site with pocket depth >5mm until overflow noticed. Antimicrobial peptide (AMP) will be reapplied for 2 more times at an interval of 3 days. Antimicrobial peptide gel Ace Helper™ contained 0.85% synthetic AMP (TAPS-18) designed based on the basic structure of cathelicidin, hydroxyethyl cellulose, and purified water. Receives: Drug: 0.85% synthetic antimicrobial peptide TAPS-18 |
| control group (normal saline) | Sham comparator | Half of the dentition will receive scaling and root surface debridement within a week followed by the irrigation of 0.9% normal saline into the site with pocket depth >5mm. Normal saline irrigation will be repeated for 2 more times at an interval of 3 days. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical measurement of pocket depth (mm)
changes in pocket depth after the test and control intervention. pocket depth is measured from the gingival margin to base of pocket using UNC-15 probe
Measured: 6 weeks and 12 weeks
clinical measurement of clinical attachment level (mm)
changes in clinical attachment level after the test and control intervention. clinical attachment level is measured from cemento-enamel junction to base of pocket using UNC-15 probe.
Measured: 6 weeks and 12 weeks
metagenomic analysis of the relative abundance (%) of bacterial from subgingival plaque
changes in relative abundance of bacterial after the test and control intervention is measured by the metagenomic analysis using subgingival plaque
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tan Hooi Shan, University of Malaya
- Investigators
- Hooi Shan, Principal investigator, faculty of dentistry, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125718
- Sponsor's protocol ID
- AMP-01
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Metagenomic Investigation of Locally Delivered Synthetic Antimicrobial Peptide Gel in Non-surgical Periodontal Treatment: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05125718
- Acronym / sponsor ID
- AMP-01
- Conditions
- Periodontitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Nov 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.
Background and objective(s): Periodontitis is initiated by a dysbiotic host-microbe relationship. Standard periodontal treatment involves oral hygiene education, mechanical debridement and periodic follow-ups with the aims of pocket closure and maintaining a symbiotic microbial community. Nonetheless, this therapy alone may fail due to the limitations of mechanical instrumentation. The use of antimicrobial in combination to subgingival debridement has been proposed for initial and recurrent periodontitis to enhance the effectiveness of mechanical instrumentation. Antimicrobial peptide (AMP) comprised of a wide range of peptide, was found naturally in various life forms or manufactured as a synthetic compound. This study was conducted to evaluate the use of AMP as an adjunct to non-surgical periodontal treatment in terms of clinical and microbiological outcomes.
Hypothesis
- There are changes in clinical periodontal parameters and subgingival microbial profile following treatment with locally delivered synthetic AMP.
Detailed description
study design: This was a split-mouth randomised pilot study of a 3-months follow-up.
Sample size calculation: The sample size was calculated using G*Power software version 3.1.9.4 (Franz Faul, Universitat Kiel, Germany). Estimation of sample size was based on the mean and standard deviation of CAL between the test and control group of previous publication (Singh et al., 2018). Four samples in each group (test and control) were required to achieve 80% power at a significant level of 5%.
Randomisation: The random allocation sequence was generated by another person who was not directly involved in the study using a Research Randomizer tools (https://www.randomizer.org/). Periodontal sites of each patient were randomised at a split mouth level (left or right halves of the dentition) to one of the two treatment groups. Allocated treatments were inserted into an opaque envelop. Treatment allocation was concealed from the clinician and only revealed once subgingival debridement was completed.
intervention: At baseline, clinical measurement was recorded and target sites (sites with PPD ≥6mm) were identified. subgingival plaque were collected at target sites. The same clinician performed full mouth scaling and subgingival debridement, coupled with standardised oral hygiene instruction for all subjects. Upon the completion of treatment, second clinician applied the treatments according to the randomisation.
- Test group: Subgingival instrumentation followed by Antimcrobial peptide gel (AMP) application in all target sites.
- Control group: Subgingival instrumentation and normal saline irrigation in all target sites.
Test and control intervention will be repeated for another 2 applications at an interval of 3 days. Subjects were re-examined and plaque sampling will be repeated at 6 weeks and 12 weeks.
statistical analysis: Clinical parameters were reported as mean and standard deviation. P-value <0.05 was considered statistically significant. intergroup and intragroup comparison of mean bleeding score, pocket depth, clinical attachment level will be conducted using SPSS software. For the metagenomic data, alpha and beta diversity were computed using QIIME 2. The difference in the relative abundance of individual genus over time will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- split-mouth study
| Arm | Type | Receives |
|---|---|---|
| test group (antimicrobial peptide) | Experimental | Drug: 0.85% synthetic antimicrobial peptide TAPS-18Half of the dentition will receive scaling and root surface debridement within a week followed by the application of antimicrobial peptide gel Ace Helper™ into the site with pocket depth >5mm until overflow noticed. Antimicrobial peptide (AMP) will be reapplied for 2 more times at an interval of 3 days. Antimicrobial peptide gel Ace Helper™ contained 0.85% synthetic AMP (TAPS-18) designed based on the basic structure of cathelicidin, hydroxyethyl cellulose, and purified water. |
| control group (normal saline) | Sham comparator | Drug: 0.9% normal salineHalf of the dentition will receive scaling and root surface debridement within a week followed by the irrigation of 0.9% normal saline into the site with pocket depth >5mm. Normal saline irrigation will be repeated for 2 more times at an interval of 3 days. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Subject diagnosed with generalised periodontitis Stage III of any grade (Caton et al., 2018).
Key exclusion criteria (6 listed)
- • Received subgingival scaling in the previous 6 months.
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 |
|---|---|---|
| 0.85% synthetic antimicrobial peptide TAPS-18Also: antimicrobial peptide gel Ace Helper™commercially available synthetic antimicrobial peptide gel for periodontal disease treatment | Drug | test group (antimicrobial peptide) |
| 0.9% normal salineAlso: RinsCap Normal Saline Sodium Chloride Irrigation Solutioncommercially available normal saline Sodium Chloride irrigation solution | Drug | control group (normal saline) |
Primary outcome
clinical measurement of pocket depth (mm)
Time frame: 6 weeks and 12 weeks
changes in pocket depth after the test and control intervention. pocket depth is measured from the gingival margin to base of pocket using UNC-15 probe
clinical measurement of clinical attachment level (mm)
Time frame: 6 weeks and 12 weeks
changes in clinical attachment level after the test and control intervention. clinical attachment level is measured from cemento-enamel junction to base of pocket using UNC-15 probe.
metagenomic analysis of the relative abundance (%) of bacterial from subgingival plaque
Time frame: 6 weeks and 12 weeks
changes in relative abundance of bacterial after the test and control intervention is measured by the metagenomic analysis using subgingival plaque
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 18 Nov 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.
Hooi Shan principal investigator
faculty of dentistry, University of Malaya
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 0.85% synthetic antimicrobial peptide TAPS-18 and 0.9% normal saline in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.
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 18 Nov 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 Malaysia. 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?
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?
clinical measurement of pocket depth (mm) (time frame: 6 weeks and 12 weeks). The study lists 3 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 18 Nov 2021.