Chronic PeriodontitisPhase 2RCTNCT04698317
Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial
A Phase 2 study testing open flap debridement, use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors and use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in people with Chronic Periodontitis and Intrabony Periodontal Defect, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Intrabony Periodontal Defect, Concentrated Growth Factors
- What is being tested?
- open flap debridement, use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors and use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jul 2021
- Phase
- Phase 2
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy patients were selected
- patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- Patients should demonstrate their ability to maintain good oral hygiene
Who cannot join
- Smokers and pregnant patients.
- Medically compromised patients and systemic conditions precluding periodontal surgery.
- Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
- Sites with tooth mobility
- Restoration or caries in the site to be treated or non-vital tooth
- Restoration or caries in the site to be treated or non-vital tooth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biodegradable Gelatin Sponge Loaded With Beta-Tricalcium Phosphate Sponges Incorporating Concentrated Growth Factors in the Treatment of Intra-bony Pocket Randomized Clinical and Radiographic Study
This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.
Read the detailed description
40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.
(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.
- Being tested
- open flap debridement, use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors, use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
- Keywords
- Beta-Tricalcium Phosphate, regeneration, concentrated growth factors
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open flap debridementProcedure or surgery
Also called periodontal surgery
Open flap for removal of diseased periodontal tissues and necrotic cementum
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factorsOther
Also called regenerative surgery
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate aloneOther
Also called Regenerative surgery
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect
| Study group | Role | What they receive |
|---|---|---|
| beta-tricalcium phosphate plus concentrated growth factors | Experimental | surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group). Receives: Procedure: open flap debridement; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors |
| beta tricalcium phosphate alone(control group) | Placebo comparator | surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), Receives: Procedure: open flap debridement; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index
gingival index will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 6months
bleeding on probing
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 6 months
probing pocket depth
probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 6 months
clinical attachment level
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 6 months
cone beam x ray measuring defect area
defect area will be recorded at baseline, and 6 months at the site to be treated
Measured: 6 months
cone beam x ray measuring bone density
bone density will be recorded at baseline, and 6 months at the site to be treated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, malak mohamed shoukheba, Tanta University
- Investigators
- malak m shoukheba, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698317
- Sponsor's protocol ID
- ≤ ≥ ° ± µ ™ ®
- Acronym
- RCT
- Status last verified
- Oct 2021
- First submitted
- 31 Dec 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodegradable Gelatin Sponge Loaded With Beta-Tricalcium Phosphate Sponges Incorporating Concentrated Growth Factors in the Treatment of Intra-bony Pocket Randomized Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT04698317
- Acronym / sponsor ID
- RCT / ≤ ≥ ° ± µ ™ ®
- Keywords
- Beta-Tricalcium Phosphate, regeneration, concentrated growth factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 6 Jan 2021 (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.
This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.
Detailed description
40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.
(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
| Arm | Type | Receives |
|---|---|---|
| beta-tricalcium phosphate plus concentrated growth factors | Experimental | Procedure: open flap debridement, Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factorssurgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group). |
| beta tricalcium phosphate alone(control group) | Placebo comparator | Procedure: open flap debridement, Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alonesurgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemically healthy patients were selected
- patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- Patients should demonstrate their ability to maintain good oral hygiene
Key exclusion criteria (6 listed)
- Smokers and pregnant patients.
- Medically compromised patients and systemic conditions precluding periodontal surgery.
- Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
- Sites with tooth mobility
- Restoration or caries in the site to be treated or non-vital tooth
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 debridementAlso: periodontal surgeryOpen flap for removal of diseased periodontal tissues and necrotic cementum | Procedure or surgery | beta tricalcium phosphate alone(control group), beta-tricalcium phosphate plus concentrated growth factors |
| use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factorsAlso: regenerative surgeryuse of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect | Other | beta-tricalcium phosphate plus concentrated growth factors |
| use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate aloneAlso: Regenerative surgeryuse of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect | Other | beta tricalcium phosphate alone(control group) |
Primary outcome
gingival index
Time frame: 6months
gingival index will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing
Time frame: 6 months
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
probing pocket depth
Time frame: 6 months
probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level
Time frame: 6 months
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring defect area
Time frame: 6 months
defect area will be recorded at baseline, and 6 months at the site to be treated
cone beam x ray measuring bone density
Time frame: 6 months
bone density will be recorded at baseline, and 6 months at the site to be treated
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 4 Oct 2021.
- Individual participant dataSharing planned: No
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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.
malak m shoukheba principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing open flap debridement, use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors and use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in people with Chronic Periodontitis and Intrabony Periodontal Defect, 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 4 Oct 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
gingival index (time frame: 6months). The study lists 6 primary outcomes in all. 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 4 Oct 2021.