Periodontitis (Stage 3)NCT07111533
Autogenous Periosteal Pedicle Graft Versus Pericardium Membrane in Management of Periodontal Intrabony Defects in Stage III Periodontitis
A study testing Open Flap Debridement (OFD), Bone Graft and Autogenous Periosteal Pedicle Graft (PPG) in people with Periodontitis (Stage 3), run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3)
- What is being tested?
- Open Flap Debridement (OFD), Bone Graft and Autogenous Periosteal Pedicle Graft (PPG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, Minia University
Minya, Minya Governorate, 61519
About this study
The aim of this study is to compare between autogenous PPG and Pericardium membrane in management of periodontal intrabody defects in stage III periodontitis.
Read the detailed description
Periodontitis is a chronic infectious disease that causes damage to periodontal tissues. One of its consequences is alveolar bone resorption, which generates horizontal or vertical bone defects and supra- or intrabony defects, causing mobility and tooth loss.
Periodontal regeneration refers to the restoration of bone, cementum and periodontal ligament to their original levels once damaged by periodontal disease. It has been shown that periodontal regeneration can be achieved by a variety of nonsurgical and surgical procedures.
Surgical modalities of periodontal regeneration include osseous grafts, guided tissue regeneration and a combination of both , Often, a new junctional epithelium is present between the regenerated alveolar bone and the previously diseased root surface.
For intrabony defects regenerative interventions included the use of enamel matrix derivatives, bone grafts, guided tissue regeneration (GTR), and biologic modifiers to achieve regeneration.
GTR is a barrier technique used for the treatment of periodontal bone defects. Guided bone regeneration (GBR) is used to enhance bone growth of the alveolus for implant placement and around peri-implant defects.
The aim of the GTR procedure is to restore destroyed periodontal support. Indeed, the placement of a physical barrier between the surgical flap and the root surface can exclude the epithelium from the healing process and can protect the blood coagulum, promoting its adherence to the root surface .
An ideal GTR membrane should possess the following promising features: appropriate mechanical strength, biocompatibility, active osteogenic property, and antibacterial strength.
Several nonresorbable and bioabsorbable materials have been used as barrier membranes in the GTR procedure , Among these, autogenous periosteal grafts, as both free and pedicle grafts, have been proposed for the treatment of periodontal defects .
The periosteum consists of three allocated zones. The first zone predominantly comprises osteoblasts; they represent 90% of the total cell population in this layer, with collagen fibrils constituting 15% of the volume. The second zone primarily consists of fibroblasts, and endothelial cells constitute the remaining spaces. The third zone is fibrous indicating the presence of the highest amount of collagen fibers and fibroblasts. The presence of such an extensive population of osteoprogenitor cells makes it an attractive tool for periodontal regeneration .
Autogenous periosteal grafts are an attractive alternative to existing barrier membrane materials since they meet the requirements of an ideal material, and they are biologically accepted. Moreover, periosteum has the potential to stimulate osteogenesis in the bony defect area .
The advantages of using an autogenous periosteal membrane are that it requires only one surgical procedure, minimizes any undesirable tissue responses during healing and has the potential for stimulating new bone formation .
Marginal periosteal pedicle (MPP) graft was introduced by Gamal and Mail-hot as a biologic GTR membrane as an attempt to manage deep angular two- and three-wall intrabony periodontal defects.
Moreover, MPP graft was examined clinically and histologically as a biologic guided tissue membrane. Not only clinical improvement was observed but also, histologic evaluation of test samples revealed coarse-fibered woven bone filling the defect nine months following therapy in three of the 10 examined newly formed tissue samples and a homogenous layer of cementum-like tissue deposition was detected in apical root notches of such samples.
The choice of using autogenous periosteal pedicle grafts was based on their biological compatibility, high vascularity, rich and diverse cellularity, acceptable rigidity, and strong regenerative capability.
A common bioresorbable barrier membrane used in GTR is collagen membrane which is made of natural polymers. The most common natural polymers used for collagen membrane fabrication are collagen type I and type III.
Natural collagen is extracted by decellularization and removal of antigenic components from primary sources which include but are not limited to porcine skin, porcine pericardium, and bovine tendon.
Some drawbacks of using a biodegradable collagen membrane include difficulties in regulating the degradation process, limited mechanical strength, the presence of residual cross-linking agents, and the potential risk of disease transmission .
The pericardium membranes, in comparison to other collagen membranes have shown an effective crosslinking, suggesting prolonged resorption time, Various in vitro and in vivo studies have managed to prove the bio-effectiveness of these pericardium membranes in enhancing bone augmentation.
Therefore, the present study will be undertaken to assess the regenerative capacity of autogenous periosteal pedicle graft in comparison with Pericardium membrane in management of Periodontal Intrabony Defects.
- Conditions
- Periodontitis (Stage 3)
- Being tested
- Open Flap Debridement (OFD), Bone Graft, Autogenous Periosteal Pedicle Graft (PPG), Pericardium Membrane
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Flap Debridement (OFD)Procedure or surgery
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.
Bone GraftProcedure or surgery
Bovine Xenograft material packed into the debrided defect.
Autogenous Periosteal Pedicle Graft (PPG)Procedure or surgery
- 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.
Pericardium MembraneProcedure or surgery
A pericardium membrane was adapted for defect coverage and sutured with the lingual flap with a synthetic 6-0 bioabsorbable Vicryl suture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Open Flap Debridement (OFD); Procedure: Bone Graft; Procedure: Autogenous Periosteal Pedicle Graft (PPG) |
| 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. Receives: Procedure: Open Flap Debridement (OFD); Procedure: Bone Graft; Procedure: Pericardium Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
Change in Probing Depth (PD) from Baseline to 6 Months
Distance from the gingival margin to the base of the pocket, measured in millimeters (mm) using a UNC-15 probe.
Measured: Baseline, 3 months, and 6 months
Change in Plaque Index (PI) from Baseline to 6 Months
Accumulation of plaque measured as a score (0-3).
Measured: Baseline, 3 months, and 6 months
Change in Gingival Index (GI) from Baseline to 6 Months
Gingival inflammation measured as a score (0-3)
Measured: Baseline, 3 months, and 6 months
Radiographic Bone Fill Measured by Cone Beam Computed Tomography (CBCT) from Baseline to 6 Months
Measurement of intrabony defect depth in millimeters (mm) and angle in degrees(°) using CBCT at baseline and 6 months postoperatively.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Ahmed Abd Elaziz Hassanien, Minia University
- Investigators
- Ahmed A Khalil, professor, Study chair, Minia UniversityAya Allah k Abd El-al, Lecturer, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111533
- Sponsor's protocol ID
- PPG vs CM in periodontitis ttt
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Periosteal Pedicle Graft Versus Pericardium Membrane in Management of Periodontal Intrabony Defects in Stage III Periodontitis
- ClinicalTrials.gov ID
- NCT07111533
- Acronym / sponsor ID
- PPG vs CM in periodontitis ttt
- Conditions
- Periodontitis (Stage 3)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare between autogenous PPG and Pericardium membrane in management of periodontal intrabody defects in stage III periodontitis.
Detailed description
Periodontitis is a chronic infectious disease that causes damage to periodontal tissues. One of its consequences is alveolar bone resorption, which generates horizontal or vertical bone defects and supra- or intrabony defects, causing mobility and tooth loss.
Periodontal regeneration refers to the restoration of bone, cementum and periodontal ligament to their original levels once damaged by periodontal disease. It has been shown that periodontal regeneration can be achieved by a variety of nonsurgical and surgical procedures.
Surgical modalities of periodontal regeneration include osseous grafts, guided tissue regeneration and a combination of both , Often, a new junctional epithelium is present between the regenerated alveolar bone and the previously diseased root surface.
For intrabony defects regenerative interventions included the use of enamel matrix derivatives, bone grafts, guided tissue regeneration (GTR), and biologic modifiers to achieve regeneration.
GTR is a barrier technique used for the treatment of periodontal bone defects. Guided bone regeneration (GBR) is used to enhance bone growth of the alveolus for implant placement and around peri-implant defects.
The aim of the GTR procedure is to restore destroyed periodontal support. Indeed, the placement of a physical barrier between the surgical flap and the root surface can exclude the epithelium from the healing process and can protect the blood coagulum, promoting its adherence to the root surface .
An ideal GTR membrane should possess the following promising features: appropriate mechanical strength, biocompatibility, active osteogenic property, and antibacterial strength.
Several nonresorbable and bioabsorbable materials have been used as barrier membranes in the GTR procedure , Among these, autogenous periosteal grafts, as both free and pedicle grafts, have been proposed for the treatment of periodontal defects .
The periosteum consists of three allocated zones. The first zone predominantly comprises osteoblasts; they represent 90% of the total cell population in this layer, with collagen fibrils constituting 15% of the volume. The second zone primarily consists of fibroblasts, and endothelial cells constitute the remaining spaces. The third zone is fibrous indicating the presence of the highest amount of collagen fibers and fibroblasts. The presence of such an extensive population of osteoprogenitor cells makes it an attractive tool for periodontal regeneration .
Autogenous periosteal grafts are an attractive alternative to existing barrier membrane materials since they meet the requirements of an ideal material, and they are biologically accepted. Moreover, periosteum has the potential to stimulate osteogenesis in the bony defect area .
The advantages of using an autogenous periosteal membrane are that it requires only one surgical procedure, minimizes any undesirable tissue responses during healing and has the potential for stimulating new bone formation .
Marginal periosteal pedicle (MPP) graft was introduced by Gamal and Mail-hot as a biologic GTR membrane as an attempt to manage deep angular two- and three-wall intrabony periodontal defects.
Moreover, MPP graft was examined clinically and histologically as a biologic guided tissue membrane. Not only clinical improvement was observed but also, histologic evaluation of test samples revealed coarse-fibered woven bone filling the defect nine months following therapy in three of the 10 examined newly formed tissue samples and a homogenous layer of cementum-like tissue deposition was detected in apical root notches of such samples.
The choice of using autogenous periosteal pedicle grafts was based on their biological compatibility, high vascularity, rich and diverse cellularity, acceptable rigidity, and strong regenerative capability.
A common bioresorbable barrier membrane used in GTR is collagen membrane which is made of natural polymers. The most common natural polymers used for collagen membrane fabrication are collagen type I and type III.
Natural collagen is extracted by decellularization and removal of antigenic components from primary sources which include but are not limited to porcine skin, porcine pericardium, and bovine tendon.
Some drawbacks of using a biodegradable collagen membrane include difficulties in regulating the degradation process, limited mechanical strength, the presence of residual cross-linking agents, and the potential risk of disease transmission .
The pericardium membranes, in comparison to other collagen membranes have shown an effective crosslinking, suggesting prolonged resorption time, Various in vitro and in vivo studies have managed to prove the bio-effectiveness of these pericardium membranes in enhancing bone augmentation.
Therefore, the present study will be undertaken to assess the regenerative capacity of autogenous periosteal pedicle graft in comparison with Pericardium membrane in management of Periodontal Intrabony Defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft). | Active comparator | Procedure: Open Flap Debridement (OFD), Procedure: Bone Graft, Procedure: Autogenous Periosteal Pedicle Graft (PPG)● 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 | Procedure: Open Flap Debridement (OFD), Procedure: Bone Graft, Procedure: Pericardium Membrane● 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Flap Debridement (OFD)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. | Procedure or surgery | Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft)., Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft). |
| Bone GraftBovine Xenograft material packed into the debrided defect. | Procedure or surgery | Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft)., Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft). |
| Autogenous Periosteal Pedicle Graft (PPG)* 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. | Procedure or surgery | Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft). |
| Pericardium MembraneA pericardium membrane was adapted for defect coverage and sutured with the lingual flap with a synthetic 6-0 bioabsorbable Vicryl suture. | Procedure or surgery | Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft). |
Primary outcome
Change in Clinical Attachment Level (CAL) from Baseline to 6 Months
Time frame: Baseline, 3 months, and 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.
4 secondary outcomes
Change in Probing Depth (PD) from Baseline to 6 Months
Time frame: Baseline, 3 months, and 6 months
Change in Plaque Index (PI) from Baseline to 6 Months
Time frame: Baseline, 3 months, and 6 months
Change in Gingival Index (GI) from Baseline to 6 Months
Time frame: Baseline, 3 months, and 6 months
Radiographic Bone Fill Measured by Cone Beam Computed Tomography (CBCT) from Baseline to 6 Months
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Khalil, professor study chair
Minia University
Aya Allah k Abd El-al, Lecturer study director
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Flap Debridement (OFD), Bone Graft and Autogenous Periosteal Pedicle Graft (PPG) in people with Periodontitis (Stage 3), run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Attachment Level (CAL) from Baseline to 6 Months (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.