Trial Outcomes & Findings for Activated MMP-8 as Diagnostic Test for Periodontitis (NCT NCT02280122)

Results Overview

First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit \[21\]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

5 minutes

Results posted on

2015-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate Chronic Periodontitis * Sites with probing pocket depths (PPD) ≥ 3.5 mm * Attachment loss (PAL-V) 3-4 mm \> 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites * no Intervention provided no intervention provided: No Intervention was rendered but the aMMP-8 test was made	Severe Chronic Periodontitis * Sites with probing PPD ≥ 3.5 mm * PAL-V ≥ 5 mm \> 30% of sites * no Intervention provided no intervention provided: No Intervention was rendered but the aMMP-8 test was made	Periodontally Healthy * PPD ≤ 3 mm * PAL-V ≤ 2 mm at \< 30% of sites * BOP \< 20% * No radiographically detectable bone loss: distance cemento-enamel junction to provided * no Intervention but aMMP-8 test no intervention provided: No Intervention was rendered but the aMMP-8 test was made
Overall Study STARTED	15	15	30
Overall Study COMPLETED	15	15	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Activated MMP-8 as Diagnostic Test for Periodontitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Generalised Moderate to Severe Chronic Periodontitis n=30 Participants * Sites with probing pocket depths (PPD) ≥ 3.5 mm * Attachment loss (PAL-V) ≥ 3 mm \> 30% of sites * no Intervention provided no intervention provided: No Intervention was rendered but the aMMP-8 test was made	Periodontally Healthy n=30 Participants * PPD ≤ 3 mm * PAL-V ≤ 2 mm at \< 30% of sites * BOP \< 20% * No radiographically detectable bone loss: distance cemento-enamel junction to provided * no Intervention but aMMP-8 test no intervention provided: No Intervention was rendered but the aMMP-8 test was made	Total n=60 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 10.7 • n=99 Participants	28.4 years STANDARD_DEVIATION 7.9 • n=107 Participants	41.2 years STANDARD_DEVIATION 15.9 • n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	20 Participants n=107 Participants	34 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	10 Participants n=107 Participants	26 Participants n=206 Participants
Region of Enrollment Germany	30 participants n=99 Participants	30 participants n=107 Participants	60 participants n=206 Participants

PRIMARY outcome

Timeframe: 5 minutes

First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit \[21\]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.

Outcome measures

Outcome measures
Measure	Sensitivity: Generalised Moderate/Severe Chronic Periodontitis n=30 Participants * Sites with probing pocket depths (PPD) ≥ 3.5 mm * Attachment loss (PAL-V) ≥ 3 mm \> 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites * no Intervention provided no intervention provided: No Intervention was rendered but the aMMP-8 test was made	Specificity: Periodontally Healthy n=30 Participants * PPD ≤ 3 mm * PAL-V ≤ 2 mm at \< 30% of sites * BOP \< 20% * No radiographically detectable bone loss: distance cemento-enamel junction to provided * no Intervention but aMMP-8 test no intervention provided: No Intervention was rendered but the aMMP-8 test was made
Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)	87 percentage of true cases (sens./spec.) Interval 68.0 to 96.0	60 percentage of true cases (sens./spec.) Interval 41.0 to 77.0

Adverse Events

Generalized Moderate to Severe Chronic Periodontitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Periodontally Healthy

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

Prof. Dr. Peter Eickholz

JWGUniversity

Phone: +49696301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place