Bovine BoneNCT07108790
Bovine Bone With or Without Concentrated Growth Factor in the Treatment of Chronic Periodontitis
A study testing Concentrated growth factors, collagen membrane and xenograft bone graft and Collagen membrane and xenograft bone graft in people with Bovine Bone and Concentrated Growth Factor, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare bovine bone with or without concentrated growth factor in the treatment of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bovine Bone, Concentrated Growth Factor, Chronic Periodontitis
- What is being tested?
- Concentrated growth factors, collagen membrane and xenograft bone graft and Collagen membrane and xenograft bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of angular periodontal intra-bony defects with a pocket depth (PD) ≥ 5mm.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
- Full-mouth bleeding score ≤ 25%.
Who cannot join
- Patients with relevant medical conditions that may affect periodontal regeneration and periodontal surgery.
- Patients who have any disease or take any medication that affects the normal number or function of platelets.
- Smokers.
- Pregnant or lactating women.
- Patients in whom periodontal surgery had previously been carried out on the selected site.
- Patients with aggressive periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Bovine Bone With or Without Concentrated Growth Factor in the Treatment of Chronic Periodontitis
The aim of this study is to compare bovine bone with or without concentrated growth factor in the treatment of chronic periodontitis.
Read the detailed description
Periodontitis is an infection-driven inflammatory disease resulting from dental plaque accumulation at the gingival margin, triggering an inflammatory response that leads to microbial alterations and may have severe consequences for the periodontium of susceptible individuals.
The xenograft most commonly used in periodontal regeneration procedures is the deproteinized bovine or equine bone mineral.
Platelets are known to play a significant role in guided tissue regeneration (GTR) by releasing several growth factors, such as platelet-derived growth factor (PDGF), and plasma rich in growth factors (PRGF), which are present in platelet-rich plasma (PRP), a first-generation platelet concentrate. Platelet-rich fibrin (PRF) and concentrated growth factors (CGF) are considered the second generation of platelet concentrate.
- Being tested
- Concentrated growth factors, collagen membrane and xenograft bone graft, Collagen membrane and xenograft bone graft
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated growth factors, collagen membrane and xenograft bone graftOther
Ten sites were treated by concentrated growth factors (CGF), collagen membrane, and xenograft bone graft.
Collagen membrane and xenograft bone graftOther
Ten sites were treated with a collagen membrane and a xenograft bone graft.
| Study group | Role | What they receive |
|---|---|---|
| Group Ι | Experimental | Ten sites were treated by concentrated growth factors (CGF), collagen membrane, and xenograft bone graft. Receives: Other: Concentrated growth factors, collagen membrane and xenograft bone graft |
| Group ΙΙ | Active comparator | Ten sites were treated with a collagen membrane and a xenograft bone graft. Receives: Other: Collagen membrane and xenograft bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket depth
Probing Pocket depth (PPD) was measured.
Measured: 6 months post-procedure
Secondary outcomes (3)
Clinical attachment level
Clinical attachment level (CAL) was measured.
Measured: 6 months post-procedure
Bleeding on probing
Bleeding on probing (BOP) was measured.
Measured: 6 months post-procedure
Plaque index
Plaque index (PI) was measured.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Mar 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bovine BoneStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Elsayed Elbadawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108790
- Sponsor's protocol ID
- R-OMPDR-3-22-11
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Bovine Bone With or Without Concentrated Growth Factor in the Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT07108790
- Acronym / sponsor ID
- R-OMPDR-3-22-11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 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 bovine bone with or without concentrated growth factor in the treatment of chronic periodontitis.
Detailed description
Periodontitis is an infection-driven inflammatory disease resulting from dental plaque accumulation at the gingival margin, triggering an inflammatory response that leads to microbial alterations and may have severe consequences for the periodontium of susceptible individuals.
The xenograft most commonly used in periodontal regeneration procedures is the deproteinized bovine or equine bone mineral.
Platelets are known to play a significant role in guided tissue regeneration (GTR) by releasing several growth factors, such as platelet-derived growth factor (PDGF), and plasma rich in growth factors (PRGF), which are present in platelet-rich plasma (PRP), a first-generation platelet concentrate. Platelet-rich fibrin (PRF) and concentrated growth factors (CGF) are considered the second generation of platelet concentrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Ι | Experimental | Other: Concentrated growth factors, collagen membrane and xenograft bone graftTen sites were treated by concentrated growth factors (CGF), collagen membrane, and xenograft bone graft. |
| Group ΙΙ | Active comparator | Other: Collagen membrane and xenograft bone graftTen sites were treated with a collagen membrane and a xenograft bone graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of angular periodontal intra-bony defects with a pocket depth (PD) ≥ 5mm.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
- Full-mouth bleeding score ≤ 25%.
Key exclusion criteria (6 listed)
- Patients with relevant medical conditions that may affect periodontal regeneration and periodontal surgery.
- Patients who have any disease or take any medication that affects the normal number or function of platelets.
- Smokers.
- Pregnant or lactating women.
- Patients in whom periodontal surgery had previously been carried out on the selected site.
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 |
|---|---|---|
| Concentrated growth factors, collagen membrane and xenograft bone graftTen sites were treated by concentrated growth factors (CGF), collagen membrane, and xenograft bone graft. | Other | Group Ι |
| Collagen membrane and xenograft bone graftTen sites were treated with a collagen membrane and a xenograft bone graft. | Other | Group ΙΙ |
Primary outcome
Probing Pocket depth
Time frame: 6 months post-procedure
Probing Pocket depth (PPD) was measured.
3 secondary outcomes
Clinical attachment level
Time frame: 6 months post-procedure
Bleeding on probing
Time frame: 6 months post-procedure
Plaque index
Time frame: 6 months post-procedure
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 7 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated growth factors, collagen membrane and xenograft bone graft and Collagen membrane and xenograft bone graft in people with Bovine Bone and Concentrated Growth Factor, run by Tanta 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 3 inclusion and 6 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 7 Aug 2025. 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?
Probing Pocket depth (time frame: 6 months post-procedure). 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 7 Aug 2025.