Trial Outcomes & Findings for Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm® (NCT NCT00881959)

NCT ID: NCT00881959

Last Updated: 2015-05-27

Results Overview

Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

12 months

Results posted on

2015-05-27

Participant Flow

Recruitment period was from 08 25 2009 to 04 24 2011. Subjects had a single non-adjacent Miller's class I or II gingival recession defect, greater than or equal to 2mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Subjects for this study were recruited from the PI's clinic.

Randomized

Participant milestones

Participant milestones
Measure	Arm 1: Puros Dermis Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.	Arm 2: Alloderm Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
Overall Study STARTED	38	42
Overall Study COMPLETED	36	38
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Puros Dermis Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.	Arm 2: Alloderm Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Puros Dermis n=38 Participants Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)	Group 2: Alloderm n=42 Participants Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	43.1 years STANDARD_DEVIATION 13.7 • n=5 Participants	47.4 years STANDARD_DEVIATION 14 • n=7 Participants	46.4 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	42 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Arm 1: Puros Dermis n=38 Participants Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.	Arm 2: Alloderm n=36 Participants Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
Non -Inferiority of Dermis to Alloderm	2.06 mm Standard Deviation 1.11	2.00 mm Standard Deviation 0.87

Adverse Events

Arm 1: Puros Dermis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm 2: Alloderm

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	Arm 1: Puros Dermis n=38 participants at risk Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.	Arm 2: Alloderm n=42 participants at risk Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
Infections and infestations Infection, Other	5.3% 2/38 • Number of events 2 • 12 months	0.00% 0/42 • 12 months

Additional Information

Hai Bo Wen

Zimmer Dental

Phone: 760 929 4312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60