PeriodontitisPhase 4NCT05530252

Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis

A Phase 4 study testing Oral biological antimicrobial gel, minocycline hydrochloride ointment and SRP in people with Periodontitis, run by Beijing Stomatological Hospital, Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Periodontitis
What is being tested?: Oral biological antimicrobial gel, minocycline hydrochloride ointment and SRP
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteChina
Study dates: 5 Sep 2022to 30 Jan 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At least 18 years old
Previously untreated Stage III and Grade B periodontitis by clinically and radiologically。In 2018, EEP and AAP sorted out periodontitis into four classifications (Stage I to IV) based on several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis, and three levels (grade A: low risk, grade B: moderate risk, grade C: high risk of progression) according to the rate of disease progression.
A minimum of 20 natural teeth in the mouth, and more than 4 molars.

Who cannot join

Acute oral lesions or necrotizing ulcerative periodontitis,
Having received antibiotics within 6 months or the need for antibiotic coverage during experiment,
Being allergic to minocycline,
No orthodontic treatment,
A history of systemic diseases,
Pregnancy,
Smoker

Trial locations and contacts

1 site in 1 country.

China1 site

BeijingSHCMU
Beijing

Other trials in China

About this study

Official title: Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis

Chronic periodontitis is an infectious disease of periodontal support tissues caused by bacterial biofilm, which leads to inflammation and destruction of periodontal support tissues ultimately resulting in tooth loss.In the clinic, patients with Stage III and Grade B periodontitis are difficult to gain desired outcomes on account of deep periodontal pockets, complicated anatomy, the removal of subgingival dental biofilms, and control of residual inflammation. A large number of studies have indicated that the effectiveness of local application of antibiotics as an adjunct to scaling and root planning (SRP), such as the antimicrobial and minocycline hydrochloride could affect bacterial metabolism and inhibit bioﬁlm attachment particularly in terms of pocket depth reduction and attachment level gain. However, the use of wide-spectrum antibiotics may cause some inevitable side effects including drug resistance, pathogens and probiotics were eliminated leading to diversity of microbiota diminished, and toothstaining. To solve the problems of antibiotics in the clinic, antimicrobial peptides (AMPs) may be considered as an alternative to conventional antibiotics drugs.In this randomized clinical trial, we aimed to evaluate the effects of AMPs as an addition to SRP on clinical parameters and microbiological biofilms in patients with Stage III and Grade B periodontitis.

Conditions: Periodontitis
Being tested: Oral biological antimicrobial gel, minocycline hydrochloride ointment, SRP
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral biological antimicrobial gelDrug
Also called Biokiller Oral Biological Antimicrobial Gel
The patients were divided into subgingival scaling, and Oral Biological Antimicrobial Gel was used in the periodontal pocket after scaling. The injection probe with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.
minocycline hydrochloride ointmentDrug
Also called Periocline
The patients were divided into subgingival scaling, and minocycline hydrochloride ointment was used in the periodontal pocket after scaling. The injection probe with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.
SRPOther
only scaling and root planning was performed on the patient

Study groups in NCT05530252
Study group	Role	What they receive
AMP Group	Experimental	scaling and root planning and subgingival application of antimicrobial peptide gel Receives: Drug: Oral biological antimicrobial gel
Perio Group	Active comparator	scaling and root planning and subgingival application of minocycline hydrochloride ointment Receives: Drug: minocycline hydrochloride ointment
SRP Group	Other	scaling and root planning Receives: Other: SRP

What is being measured

The primary outcome is the main question the study is designed to answer.

Periodontal Probing Depth
from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)
Measured: Change from Baseline Periodontal probing depth at 90 days
Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy)
from the cementoenamel junction, crown margin or restoration to the bottom of the pocket
Measured: Change from Baseline Attachment level at 90 days
Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.
Bleeding index :
0 = normal appearance of the gingiva and no bleeding on sulcus probing.
1. = normal appearance of the gingiva but bleeding on probing of the sulcus.
2. = bleeding on probing and gingival color change without swelling.
3. = bleeding on probing, gingival color change with mild swelling.
4. = bleeding on probing with marked gingival swelling, with or without color change.
5. = bleeding on probing, L Spontaneous bleeding, gingival color change with marked swelling, with or without ulceration.
Measured: Change from Bleeding index at 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 202230 Jan 2023

First posted7 Sep 2022
Study start5 Sep 2022
Primary completion30 Dec 2022
Study completion30 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05530252
Sponsor's protocol ID: CMUSH-IRB-KJ-PJ-2018-03
Status last verified: Apr 2024
First submitted: 2 Sep 2022
Last updated: 30 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis
ClinicalTrials.gov ID: NCT05530252
Acronym / sponsor ID: CMUSH-IRB-KJ-PJ-2018-03
Conditions: Periodontitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Beijing Stomatological Hospital, Capital Medical UniversityUniversity, hospital or other
Study start: 5 Sep 2022 (actual)
Primary completion: 30 Dec 2022 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 7 Sep 2022 (actual)
Results: Posted 30 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
AMP Group	Experimental	Drug: Oral biological antimicrobial gelscaling and root planning and subgingival application of antimicrobial peptide gel
Perio Group	Active comparator	Drug: minocycline hydrochloride ointmentscaling and root planning and subgingival application of minocycline hydrochloride ointment
SRP Group	Other	Other: SRPscaling and root planning

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 18 years old
Previously untreated Stage III and Grade B periodontitis by clinically and radiologically。In 2018, EEP and AAP sorted out periodontitis into four classifications (Stage I to IV) based on several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis, and three levels (grade A: low risk, grade B: moderate risk, grade C: high risk of progression) according to the rate of disease progression.
A minimum of 20 natural teeth in the mouth, and more than 4 molars.

Key exclusion criteria (7 listed)

Acute oral lesions or necrotizing ulcerative periodontitis,
Having received antibiotics within 6 months or the need for antibiotic coverage during experiment,
Being allergic to minocycline,
No orthodontic treatment,
A history of systemic diseases,

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
Oral biological antimicrobial gelAlso: Biokiller Oral Biological Antimicrobial GelThe patients were divided into subgingival scaling, and Oral Biological Antimicrobial Gel was used in the periodontal pocket after scaling. The injection probe with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.	Drug	AMP Group
minocycline hydrochloride ointmentAlso: PerioclineThe patients were divided into subgingival scaling, and minocycline hydrochloride ointment was used in the periodontal pocket after scaling. The injection probe with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.	Drug	Perio Group
SRPonly scaling and root planning was performed on the patient	Other	SRP Group

Primary outcome

Periodontal Probing Depth
Time frame: Change from Baseline Periodontal probing depth at 90 days
from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)
Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy)
Time frame: Change from Baseline Attachment level at 90 days
from the cementoenamel junction, crown margin or restoration to the bottom of the pocket
Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.
Time frame: Change from Bleeding index at 90 days
Bleeding index : 0 = normal appearance of the gingiva and no bleeding on sulcus probing. 1. = normal appearance of the gingiva but bleeding on probing of the sulcus. 2. = bleeding on probing and gingival color change without swelling. 3. = bleeding on probing, gingival color change with mild swelling. 4. = bleeding on probing with marked gingival swelling, with or without color change. 5. = bleeding on probing, L Spontaneous bleeding, gingival color change with marked swelling, with or without ulceration.

Results and safety

Results posted to the registry on 30 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMP Group	17	16
Perio Group	17	16
SRP Group	17	16

Primary outcome: Periodontal Probing Depth

Time frame: Change from Baseline Periodontal probing depth at 90 days. Mean (Inter-Quartile Range). Unit: millimeter

Measure	AMP Group n = 16	Perio Group n = 16	SRP Group n = 16
Value	2.5 (2.4 to 2.6)	3.2 (3.1 to 3.3)	3.4 (3.3 to 3.4)

Population analysed: Three subjects did not return to the clinic as required and were not included in the final data analysis of the study

Primary outcome: Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy)

Time frame: Change from Baseline Attachment level at 90 days. Mean (Inter-Quartile Range). Unit: millimeter

Measure	AMP Group n = 16	Perio Group n = 16	SRP Group n = 16
Value	1.0 (0.9 to 1)	1.7 (1.5 to 1.9)	2.0 (1.7 to 2.2)

Population analysed: Three subjects did not return to the clinic as required and were not included in the final data analysis of the study

Primary outcome: Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.

Time frame: Change from Bleeding index at 90 days. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	AMP Group n = 16	Perio Group n = 16	SRP Group n = 16
Value	0.7 (0.6 to 0.9)	1.1 (1.0 to 1.3)	1.3 (1.2 to 1.4)

Population analysed: Three subjects did not return to the clinic as required and were not included in the final data analysis of the study

Adverse events

Time frame: 1 week ，3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AMP Group	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Perio Group	0 of 17 (0%)	0 of 17 (0%)	0 of 17
SRP Group	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
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Recruiting
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Recruiting
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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?

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 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 30 Apr 2024. 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 China. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Periodontal Probing Depth (time frame: Change from Baseline Periodontal probing depth at 90 days). 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?

On the ClinicalTrials.gov record for NCT05530252.

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 30 Apr 2024.