Intrabony Periodontal DefectPhase 1/2RCTNCT07737678
Evaluation of NIPSA Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in theTreatment of Intrabony Defects
A Phase 1/2 study testing allopastic bone graft, cross-linked hyaluronic acid and Non-Incised Papillae Surgical Approach in people with Intrabony Periodontal Defect and Periodontal Disease, run by Mansoura University.
Trial summary
Sixty patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, Egypt, according to preoperative clinical and radiographic data that will be used to evaluate the bone destruction pattern. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Intrabony Periodontal Defect, Periodontal Disease
- What is being tested?
- allopastic bone graft, cross-linked hyaluronic acid and Non-Incised Papillae Surgical Approach
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Mar 2027
- Phase
- Phase 1/2
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 35 to 65 years old.
- Patients diagnosed with stage III. Periodontitis
- Presence of isolated intrabony defect with PPD ≥ 6 mm, CAL ≥ 6 mm
- Intrabony defect depth ≥3 mm.
- Contained an intrabony defect, 3-wall intrabony defect.
- No periodontal treatment has been administered in the previous six months.
- Full-mouth plaque score ≤ 10%.
- Full-mouth bleeding score ≤ 10%. -
Who cannot join
- Smokers ≥ 10 cigarettes per day
- Patient with systemic disease.
- Pregnant or lactating patients.
- Patient who has traumatic occlusion.
- Noncompliant patient.
- Patient with multi-rooted teeth with class II \& III furcation involvement.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Non-Incised Papillae Surgical Approach Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in the Treatment of Intrabony Defects (A Randomized Controlled Clinical Trial)
Sixty patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, Egypt, according to preoperative clinical and radiographic data that will be used to evaluate the bone destruction pattern.
Read the detailed description
Periodontitis comprises a group of diseases that are inflammatory in origin and generally affect the connective tissue attachment and the teeth- supporting bone. It results from interactions between periodontal microflora and the host defense response. If left untreated, periodontitis may progress to tooth mobility and eventual tooth loss, which can adversely affect oral function and esthetics, thereby influencing patients' daily activities, social behavior and overall quality of life. The main goal of comprehensive periodontal treatment is to eliminate inflammation and prevent further destruction of the periodontium, as well as to achieve a sustainable condition in the long term. Over the past decades, significant efforts have been made to develop both materials and surgical techniques that can predictably contribute to periodontal regeneration. Among the various periodontal defects associated with periodontitis, intraosseous defects represent one of the most challenging clinical conditions due to their complex morphology and limited potential for spontaneous healing, thereby necessitating a regenerative therapeutic approach. The morphology of the intraosseous defects must be carefully considered when selecting an appropriate regenerative approach. Intrabony defect morphology is commonly classified based on the number of remaining bony walls (one-wall, two-wall, or three-wall defects, or combined configurations). Defect morphology plays a critical role in periodontal regeneration by influencing the availability of essential cellular and vascular elements. Additionally, the remaining bony walls contribute to clot stability and space maintenance, both of which are essential for successful regenerative outcomes. Deep and narrow three-wall intrabony defects provide a favorable spatial architecture and are therefore associated with the highest potential for predictable periodontal regeneration. The regeneration of intrabony defects remains a significant clinical challenge in periodontal therapy. Consequently, numerous regenerative techniques and a wide range of biomaterials have been developed to enhance biological processes and improve both the quality and quantity of newly formed periodontal tissues. Regenerative procedures include the use of bone grafts, barrier membranes, biological mediators, or combinations thereof, with the aim of facilitating true periodontal regeneration, which is histologically characterized by the formation of new root cementum, periodontal ligament, and alveolar bone. The Non-Incised Papillae Surgical Approach (NIPSA), introduced in 2018 by Moreno Rodríguez and Caffesse, is a microsurgical technique designed for the treatment of isolated, deep periodontal defects. The technique is based on a single buccal horizontal incision placed apically to the periodontal defect,while preserving the marginal and lingual tissues intact, in order to create optimal conditions for periodontal regeneration and soft-tissue preservation. .
EthOss is a bioactive synthetic alloplastic bone graft composed of 65% beta-tricalcium phosphate and 35% calcium sulfate that can be easily manipulated and adapted to intrabony defects after mixing with saline or the patient's own plasma to provide a scaffold for newly formed bones.
Hyaluronic acid has specific physical and biochemical properties in normal tissues that make it an ideal structural compound. It is detectable in all vertebrate animals and within bacterial biofilms.There is no antigenic specificity for species or tissues; thus, hyaluronic acid has a low potential for allergic or immunogenic reactions. Cross-linked hyaluronic acid represents a chemically modified form of native hyaluronic acid in which individual polymer chains are covalently interconnected, forming a three-dimensional network. This structural modification significantly enhances the mechanical stability of the material, increases its resistance to enzymatic degradation, and prolongs its persistence within the tissues compared with non-cross-linked hyaluronic acid. Consequently, cross-linked hyaluronic acid demonstrates prolonged bioavailability and sustained biological activity, making it particularly suitable for periodontal and soft-tissue regenerative procedures.Minimally invasive surgical techniques have gained increasing attention in periodontal regenerative therapy, particularly for the management of intrabony defects. The Non-Incised Papillae Surgical Approach (NIPSA) has been proposed as a treatment modality aimed at preserving soft tissues and enhancing regenerative outcomes. NIPSA involves a single incision in the mucosa apical to the bone margin delimiting the periodontal defect, maintaining the marginal and interproximal soft-tissue architecture intact. This preserved tissue acts as a "dome," protecting the regenerative space within the vertical component of the defect and preventing collapse of the interproximal soft tissues into the underlying defect. Clinical studies evaluating NIPSA have demonstrated favorable outcomes, including periodontal pocket resolution, clinical attachment level (CAL) gain, and enhanced soft-tissue preservation, with particular improvements in interproximal soft-tissue stability. However, since bone substitute materials were used in conjunction with NIPSA in all reported studies, it remains difficult to isolate the specific contribution of the bone substitutes in supporting soft tissues, preventing their collapse, and enhancing papilla preservation. In addition, regenerative biomaterials such as alloplastic bone substitutes and cross-linked hyaluronic acid have been used with NIPSA to support periodontal wound healing and tissue regeneration. However, clinical evidence, comparing the regenerative effectiveness of these biomaterials when used individually or in combination with NIPSA remains limited. Therefore, further randomized clinical and radiographic studies are required to evaluate and compare their effectiveness in the treatment of periodontal intrabony defects.
- Conditions
- Intrabony Periodontal Defect, Periodontal Disease
- Being tested
- allopastic bone graft, cross-linked hyaluronic acid, Non-Incised Papillae Surgical Approach
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allopastic bone graftDevice
A fully synthetic bone graft material composed of beta-tricalcium phosphate and calcium sulfate used to promote bone regeneration in periodontal intrabony defects.
cross-linked hyaluronic acidDrug
Cross-linked hyaluronic acid applied to enhance periodontal wound healing and support regenerative outcomes.
Non-Incised Papillae Surgical ApproachProcedure or surgery
A minimally invasive periodontal regenerative surgical technique that preserves the interdental papilla and marginal soft tissues while providing access to the intrabony defect through an apical incision.
| Study group | Role | What they receive |
|---|---|---|
| Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) | Active comparator | Twenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) for the treatment of periodontal intrabony defects. Clinical and radiographic outcomes will be evaluated during follow-up. Receives: Device: allopastic bone graft; Procedure: Non-Incised Papillae Surgical Approach |
| NIPSA with Cross-linked hyaluronic acid | Active comparator | Twenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with cross-linked hyaluronic acid for periodontal treatment . Clinical and radiographic outcomes will be evaluated during follow-up. Receives: Drug: cross-linked hyaluronic acid; Procedure: Non-Incised Papillae Surgical Approach |
| NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid | Active comparator | Twenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with a combination of alloplast bone graft and cross-linked hyaluronic acid. The combined regenerative approach will be compared with the two active comparator groups. Receives: Device: allopastic bone graft; Drug: cross-linked hyaluronic acid; Procedure: Non-Incised Papillae Surgical Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of this study are: Bone Fill.
Bone Fill.
Measured: 6 months
Secondary outcomes (1)
The Secondary outcomes of this study are: 1. Reduction in Periodontal pocket depth (PPD). 2. Changes in clinical attachment loss (CAL).
- Decrease in Periodontal pocket depth (PPD).
- Changes in clinical attachment loss (CAL)
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 posted30 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Mansoura 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMMED BANDAR MOHAMMED ALODIANI, Mansoura University
- Investigators
- Mohammed B Alodiani, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737678
- Sponsor's protocol ID
- MS.26.01.141
- Acronym
- RCT
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Incised Papillae Surgical Approach Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in the Treatment of Intrabony Defects (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07737678
- Acronym / sponsor ID
- RCT / MS.26.01.141
- Conditions
- Intrabony Periodontal Defect, Periodontal Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 30 Jul 2026 (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.
Sixty patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, Egypt, according to preoperative clinical and radiographic data that will be used to evaluate the bone destruction pattern.
Detailed description
Periodontitis comprises a group of diseases that are inflammatory in origin and generally affect the connective tissue attachment and the teeth- supporting bone. It results from interactions between periodontal microflora and the host defense response. If left untreated, periodontitis may progress to tooth mobility and eventual tooth loss, which can adversely affect oral function and esthetics, thereby influencing patients' daily activities, social behavior and overall quality of life. The main goal of comprehensive periodontal treatment is to eliminate inflammation and prevent further destruction of the periodontium, as well as to achieve a sustainable condition in the long term. Over the past decades, significant efforts have been made to develop both materials and surgical techniques that can predictably contribute to periodontal regeneration. Among the various periodontal defects associated with periodontitis, intraosseous defects represent one of the most challenging clinical conditions due to their complex morphology and limited potential for spontaneous healing, thereby necessitating a regenerative therapeutic approach. The morphology of the intraosseous defects must be carefully considered when selecting an appropriate regenerative approach. Intrabony defect morphology is commonly classified based on the number of remaining bony walls (one-wall, two-wall, or three-wall defects, or combined configurations). Defect morphology plays a critical role in periodontal regeneration by influencing the availability of essential cellular and vascular elements. Additionally, the remaining bony walls contribute to clot stability and space maintenance, both of which are essential for successful regenerative outcomes. Deep and narrow three-wall intrabony defects provide a favorable spatial architecture and are therefore associated with the highest potential for predictable periodontal regeneration. The regeneration of intrabony defects remains a significant clinical challenge in periodontal therapy. Consequently, numerous regenerative techniques and a wide range of biomaterials have been developed to enhance biological processes and improve both the quality and quantity of newly formed periodontal tissues. Regenerative procedures include the use of bone grafts, barrier membranes, biological mediators, or combinations thereof, with the aim of facilitating true periodontal regeneration, which is histologically characterized by the formation of new root cementum, periodontal ligament, and alveolar bone. The Non-Incised Papillae Surgical Approach (NIPSA), introduced in 2018 by Moreno Rodríguez and Caffesse, is a microsurgical technique designed for the treatment of isolated, deep periodontal defects. The technique is based on a single buccal horizontal incision placed apically to the periodontal defect,while preserving the marginal and lingual tissues intact, in order to create optimal conditions for periodontal regeneration and soft-tissue preservation. .
EthOss is a bioactive synthetic alloplastic bone graft composed of 65% beta-tricalcium phosphate and 35% calcium sulfate that can be easily manipulated and adapted to intrabony defects after mixing with saline or the patient's own plasma to provide a scaffold for newly formed bones.
Hyaluronic acid has specific physical and biochemical properties in normal tissues that make it an ideal structural compound. It is detectable in all vertebrate animals and within bacterial biofilms.There is no antigenic specificity for species or tissues; thus, hyaluronic acid has a low potential for allergic or immunogenic reactions. Cross-linked hyaluronic acid represents a chemically modified form of native hyaluronic acid in which individual polymer chains are covalently interconnected, forming a three-dimensional network. This structural modification significantly enhances the mechanical stability of the material, increases its resistance to enzymatic degradation, and prolongs its persistence within the tissues compared with non-cross-linked hyaluronic acid. Consequently, cross-linked hyaluronic acid demonstrates prolonged bioavailability and sustained biological activity, making it particularly suitable for periodontal and soft-tissue regenerative procedures.Minimally invasive surgical techniques have gained increasing attention in periodontal regenerative therapy, particularly for the management of intrabony defects. The Non-Incised Papillae Surgical Approach (NIPSA) has been proposed as a treatment modality aimed at preserving soft tissues and enhancing regenerative outcomes. NIPSA involves a single incision in the mucosa apical to the bone margin delimiting the periodontal defect, maintaining the marginal and interproximal soft-tissue architecture intact. This preserved tissue acts as a "dome," protecting the regenerative space within the vertical component of the defect and preventing collapse of the interproximal soft tissues into the underlying defect. Clinical studies evaluating NIPSA have demonstrated favorable outcomes, including periodontal pocket resolution, clinical attachment level (CAL) gain, and enhanced soft-tissue preservation, with particular improvements in interproximal soft-tissue stability. However, since bone substitute materials were used in conjunction with NIPSA in all reported studies, it remains difficult to isolate the specific contribution of the bone substitutes in supporting soft tissues, preventing their collapse, and enhancing papilla preservation. In addition, regenerative biomaterials such as alloplastic bone substitutes and cross-linked hyaluronic acid have been used with NIPSA to support periodontal wound healing and tissue regeneration. However, clinical evidence, comparing the regenerative effectiveness of these biomaterials when used individually or in combination with NIPSA remains limited. Therefore, further randomized clinical and radiographic studies are required to evaluate and compare their effectiveness in the treatment of periodontal intrabony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) | Active comparator | Device: allopastic bone graft, Procedure: Non-Incised Papillae Surgical ApproachTwenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) for the treatment of periodontal intrabony defects. Clinical and radiographic outcomes will be evaluated during follow-up. |
| NIPSA with Cross-linked hyaluronic acid | Active comparator | Drug: cross-linked hyaluronic acid, Procedure: Non-Incised Papillae Surgical ApproachTwenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with cross-linked hyaluronic acid for periodontal treatment . Clinical and radiographic outcomes will be evaluated during follow-up. |
| NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid | Active comparator | Device: allopastic bone graft, Drug: cross-linked hyaluronic acid, Procedure: Non-Incised Papillae Surgical ApproachTwenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with a combination of alloplast bone graft and cross-linked hyaluronic acid. The combined regenerative approach will be compared with the two active comparator groups. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range: 35 to 65 years old.
- Patients diagnosed with stage III. Periodontitis
- Presence of isolated intrabony defect with PPD ≥ 6 mm, CAL ≥ 6 mm
- Intrabony defect depth ≥3 mm.
- Contained an intrabony defect, 3-wall intrabony defect.
Key exclusion criteria (6 listed)
- Smokers ≥ 10 cigarettes per day
- Patient with systemic disease.
- Pregnant or lactating patients.
- Patient who has traumatic occlusion.
- Noncompliant patient.
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 |
|---|---|---|
| allopastic bone graftA fully synthetic bone graft material composed of beta-tricalcium phosphate and calcium sulfate used to promote bone regeneration in periodontal intrabony defects. | Device | NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid, Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) |
| cross-linked hyaluronic acidCross-linked hyaluronic acid applied to enhance periodontal wound healing and support regenerative outcomes. | Drug | NIPSA with Cross-linked hyaluronic acid, NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid |
| Non-Incised Papillae Surgical ApproachA minimally invasive periodontal regenerative surgical technique that preserves the interdental papilla and marginal soft tissues while providing access to the intrabony defect through an apical incision. | Procedure or surgery | NIPSA with Cross-linked hyaluronic acid, NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid, Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) |
Primary outcome
The primary outcomes of this study are: Bone Fill.
Time frame: 6 months
Bone Fill.
1 secondary outcome
The Secondary outcomes of this study are: 1. Reduction in Periodontal pocket depth (PPD). 2. Changes in clinical attachment loss (CAL).
Time frame: 6 months
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 4 Aug 2026.
- 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.
Mohammed B Alodiani principal investigator
Faculty of Dentistry, Mansoura University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing allopastic bone graft, cross-linked hyaluronic acid and Non-Incised Papillae Surgical Approach in people with Intrabony Periodontal Defect and Periodontal Disease, run by Mansoura University.
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 8 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Contact Mohammed B Alodiani (00966599951116 ext. 00201111391937, m.balodiani@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes of this study are: Bone Fill. (time frame: 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 4 Aug 2026.