Autogenous Periosteal Pedicle Graft Versus Pericardium Membrane in Management of Periodontal Intrabony Defects in Stage III Periodontitis
1 other identifier
interventional
14
1 country
1
Brief Summary
The aim of this study is to compare between autogenous PPG and Pericardium membrane in management of periodontal intrabody defects in stage III periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 16, 2026
March 1, 2026
5 months
August 1, 2025
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Clinical Attachment Level (CAL) from Baseline to 6 Months
The distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket will be measured in millimeters (mm) using a UNC-15 probe. Improvement in CAL indicates periodontal healing.
Baseline, 3 months, and 6 months
Secondary Outcomes (4)
Change in Probing Depth (PD) from Baseline to 6 Months
Baseline, 3 months, and 6 months
Change in Plaque Index (PI) from Baseline to 6 Months
Baseline, 3 months, and 6 months
Change in Gingival Index (GI) from Baseline to 6 Months
Baseline, 3 months, and 6 months
Radiographic Bone Fill Measured by Cone Beam Computed Tomography (CBCT) from Baseline to 6 Months
Baseline and 6 months
Study Arms (2)
Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft).
ACTIVE COMPARATOR● In Group I , OFD will be performed, then a bone graft will be packed into the defect and autogenous PPG will be adapted for defect coverage as an autogenous membrane for GTR.
Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft).
ACTIVE COMPARATOR● In Group II , OFD will be performed, then a bone graft will be packed into the defect and a pericardium membrane was adapted for defect coverage.
Interventions
Under Local Anesthesia , intrasulcular incisions using surgical blade #15c Then, a full thickness mucoperiosteal flap will be raised . Then, the granulation tissue in the intrabony defect will be debrided and the root will be planned using manual and ultrasonic instruments followed by saline and chlorohexidine irrigation till obtaining a healthy sound bone surface.
Bovine Xenograft material packed into the debrided defect.
* Vertical releasing incisions will be used if necessary for better access. * The periosteal membrane will be separated from this flap and released with one vertical incision mesially and one horizontal incision apically . Posteriorly, the periosteum remained attached to the mucoperiosteal flap for adequate blood supply. * periosteal membrane will be turned over to cover this defect completely and sutured with the lingual flap with a synthetic 6-0 bioabsorbable Vicryl suture. \*The soft tissue flap will be sutured with 5-0 nonabsorbable prolene suture material and a periodontal dressing was given.
A pericardium membrane was adapted for defect coverage and sutured with the lingual flap with a synthetic 6-0 bioabsorbable Vicryl suture.
Eligibility Criteria
You may qualify if:
- patients of both sexes aged (25-45) years old.
- Patients who exhibit signs of (stage III) periodontitis.
- Healthy individuals and free from systemic disease that may contraindicate periodontal surgery and influence the outcome of the therapy, according to the detailed questionnaire of the dental modification of the Cornell medical index .
- Patients who have not received antibiotics or any medication for at least 6 months prior to this study.
- Patients who have not undergone any type of Surgical periodontal therapy 6 months prior to the initial examination.
- Patients able to return for multiple follow-up visits.
You may not qualify if:
- Pregnant and lactating females .
- Teeth with mobility greater than Grade I according to Miller classification .
- Patients with any harmful habits, like smoking or tobacco chewing.
- Unacceptable oral hygiene after the re-evaluation of phase I therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of dentistry, Minia University
Minya, Minya Governorate, 61519, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed A Khalil, professor
Minia University
- STUDY DIRECTOR
Aya Allah k Abd El-al, Lecturer
Minia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Demonstrator
Study Record Dates
First Submitted
August 1, 2025
First Posted
August 8, 2025
Study Start
August 1, 2025
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
March 16, 2026
Record last verified: 2026-03