Trial Outcomes & Findings for Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects (NCT NCT02248103)

Results Overview

Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Periosteal Pedicle Graft autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap. Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum	Bioresorbable Collagen Membrane Equine Achilles tendon collagen barrier membrane Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	10	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Periosteal Pedicle Graft n=10 Participants autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap. Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum	Bioresorbable Collagen Membrane n=10 Participants Equine Achilles tendon collagen barrier membrane Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration	Total n=20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.81 years STANDARD_DEVIATION 8.3 • n=5 Participants	37.81 years STANDARD_DEVIATION 8.3 • n=7 Participants	37.81 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: defects

Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration

Outcome measures

Outcome measures
Measure	Periosteal Pedicle Graft n=10 Participants autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap. Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum	Bioresorbable Collagen Membrane n=10 Participants Equine Achilles tendon collagen barrier membrane Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Clinical Attachment Level Baseline CAL	6.42 mm Standard Deviation 0.56	6.15 mm Standard Deviation 0.98
Clinical Attachment Level CAL after 6 months	3.52 mm Standard Deviation 0.44	3.6 mm Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline and 6 months

Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration

Outcome measures

Outcome measures
Measure	Periosteal Pedicle Graft n=10 Participants autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap. Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum	Bioresorbable Collagen Membrane n=10 Participants Equine Achilles tendon collagen barrier membrane Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Pocket Depth Baseline PD	6.92 mm Standard Deviation 0.76	6.82 mm Standard Deviation 1.1
Pocket Depth PD after 6 months	3.17 mm Standard Deviation 0.65	3.15 mm Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline and 6 months

linear measurements collected from a digital radiography program to estimate percentage of defect fill.

Outcome measures

Outcome measures
Measure	Periosteal Pedicle Graft n=10 Participants autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap. Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum	Bioresorbable Collagen Membrane n=10 Participants Equine Achilles tendon collagen barrier membrane Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Bone Defect Area Baseline bone defect area	8.37 "mm^2" Standard Deviation 4.13	9.25 "mm^2" Standard Deviation 3.23
Bone Defect Area Bone defect area after 6 months	4.42 "mm^2" Standard Deviation 0.72	5.7 "mm^2" Standard Deviation 2.99

Adverse Events

Periosteal Pedicle Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bioresorbable Collagen Membrane

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

Ass. Prof. Dr. Noha Ghallab

Faculty of Oral and Dental Medicine Cairo University

Phone: +201005263365

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place