Trial Outcomes & Findings for Investigation of the Safety and Efficacy of Pocket-X Gel (NCT NCT03358251)

NCT ID: NCT03358251

Last Updated: 2020-09-02

Results Overview

Change in the probing depth of periodontal pockets which have undergone treatment with SRP+Pocket-X Gel in comparison to periodontal pockets which have undergone SRP only.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 12 and 24 weeks following first Pocket-X Gel administration
• Results posted on: 2020-09-02

Participant Flow

Participant milestones

Measure	SRP+Pocket-X Gel, Split-mouth The single arm is a split-mouth arm, i.e., participants will receive conventional treatment for periodontitis (scaling and root planing) for the entire mouth, and, in addition, will receive experimental treatment (Pocket-X Gel) for periodontal pockets present in one/two mouth segments (quadrants), while the contralateral quadrants will serve as control and will not undergo any further intervention.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	SRP+Pocket-X Gel, Split-mouth n=34 Participants The single arm is a split-mouth arm, i.e., participants will receive conventional treatment for periodontitis (scaling and root planing) for the entire mouth, and, in addition, will receive experimental treatment (Pocket-X Gel) for periodontal pockets present in one/two mouth segments (quadrants), while the contralateral quadrants will serve as control and will not undergo any further intervention.
Age, Continuous	51.3 years STANDARD_DEVIATION 13.1 • n=34 Participants
Sex: Female, Male Female	13 Participants n=34 Participants
Sex: Female, Male Male	21 Participants n=34 Participants
Region of Enrollment Israel	34 participants n=34 Participants

PRIMARY outcome

Timeframe: 12 and 24 weeks following first Pocket-X Gel administration

Change in the probing depth of periodontal pockets which have undergone treatment with SRP+Pocket-X Gel in comparison to periodontal pockets which have undergone SRP only.

Outcome measures

Measure	Lower Jaw Pockets + Treatment n=63 pockets Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.	Lower Jaw Pockets - Control n=63 pockets Periodontal pockets situated in the lower jaw which received a tratment of SRP only.	Upper Jaw Pockets + Treatment n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.	Upper Jaw Pockets + Control n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.
Change in Periodontal Pockets Probing Depth depth at baseline	6.97 mm Standard Deviation 1.49	6.81 mm Standard Deviation 1.59	7.67 mm Standard Deviation 1.45	7.72 mm Standard Deviation 1.30
Change in Periodontal Pockets Probing Depth depth at 3 months	5.19 mm Standard Deviation 0.98	5.69 mm Standard Deviation 1.38	5.53 mm Standard Deviation 1.07	6.35 mm Standard Deviation 1.10
Change in Periodontal Pockets Probing Depth depth at 6 months	4.5 mm Standard Deviation 0.8	5.53 mm Standard Deviation 1.24	4.74 mm Standard Deviation 0.82	7.72 mm Standard Deviation 0.99

SECONDARY outcome

Timeframe: 12 and 24 weeks following first Pocket-X Gel administration

Change in the clinical attachment level of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.

Outcome measures

Measure	Lower Jaw Pockets + Treatment n=63 pockets Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.	Lower Jaw Pockets - Control n=63 pockets Periodontal pockets situated in the lower jaw which received a tratment of SRP only.	Upper Jaw Pockets + Treatment n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.	Upper Jaw Pockets + Control n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.
Change in Clinical Attachment change in CAL after 3 months	2.08 mm Standard Deviation 0.69	0.97 mm Standard Deviation 0.64	2.62 mm Standard Deviation 0.82	1.26 mm Standard Deviation 0.68
Change in Clinical Attachment change in CAL after 6 months	3.01 mm Standard Deviation 0.92	1.06 mm Standard Deviation 0.63	3.61 mm Standard Deviation 0.94	1.44 mm Standard Deviation 0.83

SECONDARY outcome

Timeframe: 12 and 24 weeks following first Pocket-X Gel administration

Change in gingival recession level (buccal) of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only. Measured in mm.

Outcome measures

Measure	Lower Jaw Pockets + Treatment n=63 pockets Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.	Lower Jaw Pockets - Control n=63 pockets Periodontal pockets situated in the lower jaw which received a tratment of SRP only.	Upper Jaw Pockets + Treatment n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.	Upper Jaw Pockets + Control n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.
Change in Recession Level B recession at baseline	1.36 mm Standard Deviation 1.27	1.21 mm Standard Deviation 1.17	1.49 mm Standard Deviation 1.22	1.38 mm Standard Deviation 1.06
Change in Recession Level B recession at 3 months	1.06 mm Standard Deviation 1.06	1.35 mm Standard Deviation 1.32	1.01 mm Standard Deviation 0.98	1.49 mm Standard Deviation 1.24
Change in Recession Level B recession at 6 months	0.82 mm Standard Deviation 0.89	1.43 mm Standard Deviation 1.42	0.80 mm Standard Deviation 0.88	1.51 mm Standard Deviation 1.38

SECONDARY outcome

Timeframe: 12 and 24 weeks following first Pocket-X Gel administration

Change in gingival bleeding index of mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.

Outcome measures

Measure	Lower Jaw Pockets + Treatment n=63 pockets Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.	Lower Jaw Pockets - Control n=63 pockets Periodontal pockets situated in the lower jaw which received a tratment of SRP only.	Upper Jaw Pockets + Treatment n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.	Upper Jaw Pockets + Control n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.
Change in Bleeding Index percent of pockets bleeding at baseline	98.4 % percent of pockets bleeding	85.7 % percent of pockets bleeding	92.66 % percent of pockets bleeding	92.66 % percent of pockets bleeding
Change in Bleeding Index percent of pockets bleeding after 3 months	20.63 % percent of pockets bleeding	36.51 % percent of pockets bleeding	20.18 % percent of pockets bleeding	45.87 % percent of pockets bleeding
Change in Bleeding Index percent of pockets bleeding after 6 months	12.70 % percent of pockets bleeding	28.57 % percent of pockets bleeding	8.33 % percent of pockets bleeding	44.44 % percent of pockets bleeding

SECONDARY outcome

Timeframe: 12 and 24 weeks following first Pocket-X Gel administration

Change in mobility grade of teeth present in mouth segments which have undergone treatment with SRP+Pocket-X Gel in comparison to mouth segments which have undergone SRP only.

Mobility is graded clinically by applying pressure with the ends of 2 metal instruments (e.g. dental mirrors) and trying to rock a tooth gently in a bucco-lingual direction (towards the tongue and outwards again).

Normal, physiologic tooth mobility of about 0.25 mm is present in health. This is because the tooth is not fused to the bones of the jaws, but is connected to the sockets by the periodontal ligament.

Abnormal, pathologic tooth mobility occurs when the attachment of the periodontal ligament to the tooth is reduced (attachment loss), or if the periodontal ligament is inflamed. Tooth mobility is measured and graduated from 0-3.

Grade 0: No apparent mobility Grade 1: Perceptible mobility <1mm in buccolingual direction Grade 2: >1mm but <2mm Grade 3: >2mm or depressibility in the socket

Outcome measures

Measure	Lower Jaw Pockets + Treatment n=63 pockets Periodontal pockets situated in the lower jaw which received a treatment of SRP + Pocket-X gel.	Lower Jaw Pockets - Control n=63 pockets Periodontal pockets situated in the lower jaw which received a tratment of SRP only.	Upper Jaw Pockets + Treatment n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP + Pocket-X gel.	Upper Jaw Pockets + Control n=109 pockets Periodontal pockets situated in the upper jaw which received a treatment of SRP alone.
Change in Mobility Grade Mobility at baseline	0.19 mobility grade Standard Deviation 0.50	0.19 mobility grade Standard Deviation 0.53	0.18 mobility grade Standard Deviation 0.51	0.19 mobility grade Standard Deviation 0.52
Change in Mobility Grade Mobility after 3 months	0.05 mobility grade Standard Deviation 0.21	0.14 mobility grade Standard Deviation 0.50	0.05 mobility grade Standard Deviation 0.23	0.15 mobility grade Standard Deviation 0.38
Change in Mobility Grade Mobility after 6 months	0 mobility grade Standard Deviation 0	0.01 mobility grade Standard Deviation 0.12	0.01 mobility grade Standard Deviation 0.10	0.12 mobility grade Standard Deviation 0.35

Adverse Events

SRP+Pocket-X Gel, Split-mouth

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

Head of QA/RA

Prudentix Ltd.

Phone: +972-72-394-22-24

Email: tsipi@prudentix.com

Results disclosure agreements

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