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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMP Group | Experimental | scaling and root planning and subgingival application of antimicrobial peptide gel |
|
| Perio Group | Active Comparator | scaling and root planning and subgingival application of minocycline hydrochloride ointment |
|
| SRP Group | Other | scaling and root planning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral biological antimicrobial gel | Drug | 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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag. |
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal Probing Depth | from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy) | 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 | 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.
| Change from Bleeding index at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeijingSHCMU | Beijing | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | AMP Group | scaling and root planning and subgingival application of antimicrobial peptide gel 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. |
| FG001 | Perio Group | scaling and root planning and subgingival application of minocycline hydrochloride ointment minocycline hydrochloride ointment: 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. |
| FG002 | SRP Group | scaling and root planning SRP: only scaling and root planning was performed on the patient |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AMP Group | scaling and root planning and subgingival application of antimicrobial peptide gel 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Periodontal Probing Depth | from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy) | Three subjects did not return to the clinic as required and were not included in the final data analysis of the study | Posted | Mean | Inter-Quartile Range | millimeter | Change from Baseline Periodontal probing depth at 90 days |
|
1 week ，3 months
Severe drug allergy：Drug ulceration of the gums、the oral mucosa is red and swollen、laryngeal edema、local drug eruption
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMP Group | scaling and root planning and subgingival application of antimicrobial peptide gel 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Nannan Han | BeijingSHCMU | 15701545851 | qhddenver@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2022 | Nov 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2022 | Nov 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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The patients did not know their group or the drugs they were given
|
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| minocycline hydrochloride ointment | Drug | 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. |
|
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| SRP | Other | only scaling and root planning was performed on the patient |
|
| BG001 | Perio Group | scaling and root planning and subgingival application of minocycline hydrochloride ointment minocycline hydrochloride ointment: 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. |
| BG002 | SRP Group | scaling and root planning SRP: only scaling and root planning was performed on the patient |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Probing depth | Mean | Inter-Quartile Range | millimeter |
|
| OG001 | Perio Group | scaling and root planning and subgingival application of minocycline hydrochloride ointment minocycline hydrochloride ointment: 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. |
| OG002 | SRP Group | scaling and root planning SRP: only scaling and root planning was performed on the patient |
|
|
| Primary | 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 | Three subjects did not return to the clinic as required and were not included in the final data analysis of the study | Posted | Mean | Inter-Quartile Range | millimeter | Change from Baseline Attachment level at 90 days |
|
|
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| Primary | 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.
| Three subjects did not return to the clinic as required and were not included in the final data analysis of the study | Posted | Mean | Inter-Quartile Range | score on a scale | Change from Bleeding index at 90 days |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Perio Group | scaling and root planning and subgingival application of minocycline hydrochloride ointment minocycline hydrochloride ointment: 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | SRP Group | scaling and root planning SRP: only scaling and root planning was performed on the patient | 0 | 17 | 0 | 17 | 0 | 17 |
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| Male |
|