Intrabony Periodontal DefectEarly Phase 1NCT06633640
Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects
A Early Phase 1 study testing Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane. in people with Intrabony Periodontal Defect and Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
Periodontal diseases are one of the most prevalent chronic diseases involving a spectrum of inflammatory conditions. Intrabony defects, also known "vertical defects," are specific osseous and morphological defects and one of the consequences and end result of periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Intrabony Periodontal Defect, Periodontitis
- What is being tested?
- Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is between ≥ 20 to ≤ 65 years old.
- Presence of intrabony defect
- Systematically free.
- The subjects understand the purpose of the study, adhere to the study protocol and given consent to be included in the study.
- Adequate plaque control and stable periodontal status (full-mouth bleeding score on probing: <25%, and full- mouth plaque score: <25%)
Who cannot join
- Smokers
- Any infection particularly at the intervention site.
- Teeth mobility more than grade 1.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Periodontology Clinic, Faculty of Oral and Dental medicine, University of Cairo, Egypt.
Cairo
About this study
Official title: Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
Periodontal diseases are one of the most prevalent chronic diseases involving a spectrum of inflammatory conditions. Intrabony defects, also known "vertical defects," are specific osseous and morphological defects and one of the consequences and end result of periodontitis. Intrabony defects are particularly associated with periodontal progression however certain patient-related factors play important role in its management such as plaque management, smoking, medical history, tooth mobility and endodontic condition.
Periodontal repair is aimed to gain periodontal attachment using various modalities in severely compromised teeth, decrease pocket depth, and stabilize gingival recession. Different types of biomaterial substitutes and bone graft materials are available, but the choice of suitable "golden" type or technique is difficult and dependent on various factors particularly anatomical variations, cost effective, clinical situations, the systemic general condition, operation site, socioeconomic conditions and the surgeon choice.
Read more
The current therapeutic options mainly focus on minimize symptoms and prevent disease progression but are not able to fully restore damaged bone and periodontal supporting tissues. Many of these regenerative approaches, (e.g. bone grafts) provided variable and unpredictable clinical outcomes. Therefore, it is imperative to develop alternative regenerative strategies.
There is necessity to introduce novel and alternative materials of natural and synthetic origins for bone grafting use in dental field. This requires well performed clinical trials on humans to understand the effects of such materials (e.g the marine algae-based substitutes and biodegradable (absorbable) materials) either as a single or combined formula.
The aim of the current clinical study is to evaluate the clinical efficacy of an algae-based biphasic bone graft material (AlgOss 20/80) and collagen membrane in the treatment of patient with intrabony periodontal defects.
Read the detailed description
Study population Recruited patients attending the dental clinic at the faculty of dentistry of the University of Cairo, Egypt will be included following the study eligibility criteria.
Population: Patients with periodontal intrabony defects (Stage III and IV periodontitis).
Intervention: Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.
Control: Conventional flap with collagen membrane.
Outcomes:
Primary outcome:
- Clinical attachment level (CAL)
Secondary outcomes:
- Bleeding on probing (BOP)
- Plaque index (PI)
- Probing pocket depth (PPD)
- Gingival recession (GR)
- Defect depth and width
- Radiographic depth and width
- Postoperative care and satisfaction assessment
- Conditions
- Intrabony Periodontal Defect, Periodontitis
- Being tested
- Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.
- Keywords
- Algae-Based Biphasic Graft substances
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.Combination product
The graft material will be prepared following the manufacturer instruction, transferred into a sterile cup than the mixture is condensed without overfilling in the intrabony defect to the level of the surrounding bony walls. The filled site will be than covered with collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane Receives: Combination Product: Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane. |
| Control group | No intervention | Conventional flap with collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
The CAL will be measured from the cementoenamel junction (CEJ) to the base of the sulcus or pocket
Measured: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Secondary outcomes (1)
Probing pocket depth (PPD)
Probing pocket depth (PPD):
PPD is determined by measuring the distance from the gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Measured: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma Omar B. Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633640
- Sponsor's protocol ID
- 18224
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paolantonio M. Combined periodontal regenerative technique in human intrabony defects by collagen membranes and anorganic bovine bone. A controlled clinical study. J Periodontol. 2002 Feb;73(2):158-66. doi: 10.1902/jop.2002.73.2.158.
PubMed 11895280
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06633640
- Acronym / sponsor ID
- 18224
- Conditions
- Intrabony Periodontal Defect, Periodontitis
- Keywords
- Algae-Based Biphasic Graft substances
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Oct 2024 (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.
Periodontal diseases are one of the most prevalent chronic diseases involving a spectrum of inflammatory conditions. Intrabony defects, also known "vertical defects," are specific osseous and morphological defects and one of the consequences and end result of periodontitis. Intrabony defects are particularly associated with periodontal progression however certain patient-related factors play important role in its management such as plaque management, smoking, medical history, tooth mobility and endodontic condition.
Periodontal repair is aimed to gain periodontal attachment using various modalities in severely compromised teeth, decrease pocket depth, and stabilize gingival recession. Different types of biomaterial substitutes and bone graft materials are available, but the choice of suitable "golden" type or technique is difficult and dependent on various factors particularly anatomical variations, cost effective, clinical situations, the systemic general condition, operation site, socioeconomic conditions and the surgeon choice.
The current therapeutic options mainly focus on minimize symptoms and prevent disease progression but are not able to fully restore damaged bone and periodontal supporting tissues. Many of these regenerative approaches, (e.g. bone grafts) provided variable and unpredictable clinical outcomes. Therefore, it is imperative to develop alternative regenerative strategies.
There is necessity to introduce novel and alternative materials of natural and synthetic origins for bone grafting use in dental field. This requires well performed clinical trials on humans to understand the effects of such materials (e.g the marine algae-based substitutes and biodegradable (absorbable) materials) either as a single or combined formula.
The aim of the current clinical study is to evaluate the clinical efficacy of an algae-based biphasic bone graft material (AlgOss 20/80) and collagen membrane in the treatment of patient with intrabony periodontal defects.
Detailed description
Study population Recruited patients attending the dental clinic at the faculty of dentistry of the University of Cairo, Egypt will be included following the study eligibility criteria.
Population: Patients with periodontal intrabony defects (Stage III and IV periodontitis).
Intervention: Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.
Control: Conventional flap with collagen membrane.
Outcomes:
Primary outcome:
- Clinical attachment level (CAL)
Secondary outcomes:
- Bleeding on probing (BOP)
- Plaque index (PI)
- Probing pocket depth (PPD)
- Gingival recession (GR)
- Defect depth and width
- Radiographic depth and width
- Postoperative care and satisfaction assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane |
| Control group | No intervention | –Conventional flap with collagen membrane |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age is between ≥ 20 to ≤ 65 years old.
- Presence of intrabony defect
- Systematically free.
- The subjects understand the purpose of the study, adhere to the study protocol and given consent to be included in the study.
- Adequate plaque control and stable periodontal status (full-mouth bleeding score on probing: <25%, and full- mouth plaque score: <25%)
Key exclusion criteria (4 listed)
- Smokers
- Any infection particularly at the intervention site.
- Teeth mobility more than grade 1.
- Pregnant or lactating women.
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 |
|---|---|---|
| Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.The graft material will be prepared following the manufacturer instruction, transferred into a sterile cup than the mixture is condensed without overfilling in the intrabony defect to the level of the surrounding bony walls. The filled site will be than covered with collagen membrane. | Combination product | Intervention |
Primary outcome
Clinical attachment level (CAL)
Time frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
The CAL will be measured from the cementoenamel junction (CEJ) to the base of the sulcus or pocket
1 secondary outcome
Probing pocket depth (PPD)
Time frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Background: PubMed 11895280Paolantonio M. Combined periodontal regenerative technique in human intrabony defects by collagen membranes and anorganic bovine bone. A controlled clinical study. J Periodontol. 2002 Feb;73(2):158-66. doi: 10.1902/jop.2002.73.2.158.
- 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.
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 Early Phase 1 study testing Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane. in people with Intrabony Periodontal Defect and Periodontitis, run by Cairo 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 5 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: enrolling by invitation, as of the sponsor's last update on 10 Oct 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Clinical attachment level (CAL) (time frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06633640, which also lists 1 linked publication.
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 10 Oct 2024.