Trial Outcomes & Findings for Emdogain and Straumann Bone Ceramic in Infrabony Defects (NCT NCT00906776)

Results Overview

CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2016-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Emdogain PLUS Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone Autogenous bone from the patient
Overall Study STARTED	11	8
Overall Study COMPLETED	11	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Emdogain and Straumann Bone Ceramic in Infrabony Defects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emdogain PLUS n=11 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient	Total n=19 Participants Total of all reporting groups
Age, Continuous	36.9 years STANDARD_DEVIATION 8.9 • n=5 Participants	31.9 years STANDARD_DEVIATION 8.6 • n=7 Participants	34.8 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).

Outcome measures

Outcome measures
Measure	Emdogain PLUS n=11 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient
Change in Clinical Attachment Level (CAL)	-2.86 millimeters Standard Deviation 1.43	-2.44 millimeters Standard Deviation 1.08

SECONDARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Emdogain PLUS n=9 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect	-2.02 mm Standard Deviation 1.80	-2.13 mm Standard Deviation 1.47

SECONDARY outcome

Timeframe: Baseline and 12 months

PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.

Outcome measures

Outcome measures
Measure	Emdogain PLUS n=11 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient
Change in Probing Pocket Depth (PPD)	-3.36 millimeters Standard Deviation 1.42	-2.75 millimeters Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline and 6 months

CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).

Outcome measures

Outcome measures
Measure	Emdogain PLUS n=11 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient
Change in Clinical Attachment Level (CAL)	-2.44 mm Standard Deviation 0.95	-2.25 mm Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline and 6 months

PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.

Outcome measures

Outcome measures
Measure	Emdogain PLUS n=11 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient
Change in Probing Pocket Depth (PPD)	-2.78 mm Standard Deviation 1.18	-2.56 mm Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline and 12 months

Outcome measures

Outcome measures
Measure	Emdogain PLUS n=11 Participants Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 Participants Autogenous bone from the patient
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect	-2.26 mm Standard Deviation 1.99	-2.29 mm Standard Deviation 1.48

Adverse Events

Emdogain PLUS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Autogenous Bone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Emdogain PLUS n=11 participants at risk Straumann Emdogain in combination with Straumann BoneCeramic	Autogenous Bone n=8 participants at risk Autogenous bone from the patient
General disorders Pregnancy	9.1% 1/11 • Number of events 1	0.00% 0/8

Additional Information

Prof Philippe Bouchard

Rotschild hospital

Phone: +33614656947

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place