Chronic Periodontitis
Conditions
Brief summary
A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison with collagen membrane for management of periodontal intrabony defects.
Detailed description
Twenty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched pairs of two- or three-walled intrabony defects. Each pair of periodontal defects were randomly assigned into the experimental group; periosteal pedicle graft guided tissue membrane or the positive control group; bioresorbable collagen guided tissue regeneration membrane. Clinical and radiographic parameters were recorded at baseline and at 6 months postoperatively.
Interventions
PROCEDUREPeriosteal pedicle graft
Autogenous pedicle graft harvested from the periosteum
BIOLOGICALBioresorbable collagen membrane
Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Severe chronic periodontitis patients with at least two sites with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss 2- or 3-wall intrabony defect depth ranging from 3 to 6 mm as detected in periapical radiographs * The facial surface of teeth adjacent to the interproximal defect should be free of extensive recession and marginal bone loss, with at least a 4 to 5 mm band of keratinized gingiva to allow for periosteal manipulation
Exclusion criteria
* Pregnant women * Subjects had \<22 permanent teeth * Having any given systemic disease * Taking any type of medication and/or antibiotic therapy during the 3 months before the study * Received periodontal treatment within the past 12 months * Current or former smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level | Baseline and 6 months | Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Depth | Baseline and 6 months | Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration |
| Bone Defect Area | Baseline and 6 months | linear measurements collected from a digital radiography program to estimate percentage of defect fill. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Periosteal Pedicle Graft autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Periosteal Pedicle Graft | Bioresorbable Collagen Membrane | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 37.81 years STANDARD_DEVIATION 8.3 | 37.81 years STANDARD_DEVIATION 8.3 | 37.81 years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Clinical Attachment Level
Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration
Time frame: Baseline and 6 months
Population: defects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periosteal Pedicle Graft | Clinical Attachment Level | Baseline CAL | 6.42 mm | Standard Deviation 0.56 |
| Periosteal Pedicle Graft | Clinical Attachment Level | CAL after 6 months | 3.52 mm | Standard Deviation 0.44 |
| Bioresorbable Collagen Membrane | Clinical Attachment Level | Baseline CAL | 6.15 mm | Standard Deviation 0.98 |
| Bioresorbable Collagen Membrane | Clinical Attachment Level | CAL after 6 months | 3.6 mm | Standard Deviation 0.57 |
Secondary
Bone Defect Area
linear measurements collected from a digital radiography program to estimate percentage of defect fill.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periosteal Pedicle Graft | Bone Defect Area | Baseline bone defect area | 8.37 mm^2 | Standard Deviation 4.13 |
| Periosteal Pedicle Graft | Bone Defect Area | Bone defect area after 6 months | 4.42 mm^2 | Standard Deviation 0.72 |
| Bioresorbable Collagen Membrane | Bone Defect Area | Baseline bone defect area | 9.25 mm^2 | Standard Deviation 3.23 |
| Bioresorbable Collagen Membrane | Bone Defect Area | Bone defect area after 6 months | 5.7 mm^2 | Standard Deviation 2.99 |
Secondary
Pocket Depth
Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periosteal Pedicle Graft | Pocket Depth | Baseline PD | 6.92 mm | Standard Deviation 0.76 |
| Periosteal Pedicle Graft | Pocket Depth | PD after 6 months | 3.17 mm | Standard Deviation 0.65 |
| Bioresorbable Collagen Membrane | Pocket Depth | Baseline PD | 6.82 mm | Standard Deviation 1.1 |
| Bioresorbable Collagen Membrane | Pocket Depth | PD after 6 months | 3.15 mm | Standard Deviation 0.67 |