Trial Outcomes & Findings for Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis (NCT NCT05530252)

NCT ID: NCT05530252

Last Updated: 2024-04-30

Results Overview

from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: Change from Baseline Periodontal probing depth at 90 days
• Results posted on: 2024-04-30

Participant Flow

Participant milestones

Measure	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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.	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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.	SRP Group scaling and root planning SRP: only scaling and root planning was performed on the patient
Overall Study STARTED	17	17	17
Overall Study COMPLETED	16	16	16
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Measure	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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.	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.	SRP Group scaling and root planning SRP: only scaling and root planning was performed on the patient
Overall Study Lost to Follow-up	1	1	1

Baseline Characteristics

Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis

Baseline characteristics by cohort

Measure	AMP Group n=17 Participants 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.	Perio Group n=17 Participants 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.	SRP Group n=17 Participants scaling and root planning SRP: only scaling and root planning was performed on the patient	Total n=51 Participants Total of all reporting groups
Age, Continuous	38.73 years STANDARD_DEVIATION 14.03 • n=17 Participants	37.93 years STANDARD_DEVIATION 12.74 • n=17 Participants	38.50 years STANDARD_DEVIATION 10.01 • n=17 Participants	38.39 years STANDARD_DEVIATION 10.54 • n=51 Participants
Sex: Female, Male Female	11 Participants n=17 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis	10 Participants n=17 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis	10 Participants n=17 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis	31 Participants n=51 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis
Sex: Female, Male Male	6 Participants n=17 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis	7 Participants n=17 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis	7 Participants n=17 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis	20 Participants n=51 Participants • Because three subjects did not return to the clinic according to the time, they were not included in the final study analysis
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Probing depth	5.0 millimeter n=17 Participants	4.9 millimeter n=17 Participants	5.0 millimeter n=17 Participants	5.0 millimeter n=51 Participants

PRIMARY outcome

Timeframe: Change from Baseline Periodontal probing depth at 90 days

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

from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)

Outcome measures

Measure	AMP Group n=16 Participants 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.	Perio Group n=16 Participants 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.	SRP Group n=16 Participants scaling and root planning SRP: only scaling and root planning was performed on the patient
Periodontal Probing Depth	2.5 millimeter Interval 2.4 to 2.6	3.2 millimeter Interval 3.1 to 3.3	3.4 millimeter Interval 3.3 to 3.4

PRIMARY outcome

Timeframe: Change from Baseline Attachment level at 90 days

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

from the cementoenamel junction, crown margin or restoration to the bottom of the pocket

Outcome measures

Measure	AMP Group n=16 Participants 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.	Perio Group n=16 Participants 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.	SRP Group n=16 Participants scaling and root planning SRP: only scaling and root planning was performed on the patient
Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy)	1.0 millimeter Interval 0.9 to 1.0	1.7 millimeter Interval 1.5 to 1.9	2.0 millimeter Interval 1.7 to 2.2

PRIMARY outcome

Timeframe: Change from Bleeding index at 90 days

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

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.

Outcome measures

Measure	AMP Group n=16 Participants 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.	Perio Group n=16 Participants 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.	SRP Group n=16 Participants scaling and root planning SRP: only scaling and root planning was performed on the patient
Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.	0.7 score on a scale Interval 0.6 to 0.9	1.1 score on a scale Interval 1.0 to 1.3	1.3 score on a scale Interval 1.2 to 1.4

Adverse Events

AMP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Perio Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SRP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Nannan Han

BeijingSHCMU

Phone: 15701545851

Email: qhddenver@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place