Trial Outcomes & Findings for Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft (NCT NCT02697890)

Results Overview

Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

4 months after surgical procedure

Results posted on

2020-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®) Interventions: Procedure: Ridge preservation procedure FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care	FDBA (MinerOss®) + Mucograft® Seal Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®) n=14 Participants Interventions: Procedure: Ridge preservation procedure FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care	FDBA (MinerOss®) + Mucograft® Seal n=14 Participants Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration	Total n=28 Participants Total of all reporting groups
Age, Continuous	55.6 years n=5 Participants	55.1 years n=7 Participants	55.4 years 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	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months after surgical procedure

Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans

Outcome measures

Outcome measures
Measure	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®) n=14 Participants Interventions: Procedure: Ridge preservation procedure FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care	FDBA (MinerOss®) + Mucograft® Seal n=14 Participants Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration
Changes in Alveolar Bone (mm)	-1.47 mm Standard Deviation 1.29	-1.21 mm Standard Deviation 1.22

SECONDARY outcome

Timeframe: 4 months after surgical procedure

Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.

Outcome measures

Outcome measures
Measure	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®) n=14 Participants Interventions: Procedure: Ridge preservation procedure FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care	FDBA (MinerOss®) + Mucograft® Seal n=14 Participants Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration
Changes in Hard Tissues	-0.79 mm Standard Deviation 3.07	-0.30 mm Standard Deviation 1.09

SECONDARY outcome

Timeframe: 4 months after surgical procedure

Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.

Outcome measures

Outcome measures
Measure	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®) n=14 Participants Interventions: Procedure: Ridge preservation procedure FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care	FDBA (MinerOss®) + Mucograft® Seal n=14 Participants Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration
Changes in Soft Tissues	0.59 mm Standard Deviation 1.28	0.90 mm Standard Deviation 0.90

SECONDARY outcome

Timeframe: 4 months after surgical procedure

Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.

Outcome measures

Outcome measures
Measure	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®) n=14 Participants Interventions: Procedure: Ridge preservation procedure FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care	FDBA (MinerOss®) + Mucograft® Seal n=14 Participants Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration
Keratinized Tissue Width (mm)	-0.08 mm Standard Deviation 1.24	-0.08 mm Standard Deviation 0.54

Adverse Events

FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FDBA (MinerOss®) + Mucograft® Seal

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

Y. Natalie Jeong

TuftsUSDM

Phone: 6176366531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place