PeriodontitisNCT07522684
Polynucleotide + Hyaluronic Acid Gel With Xenogeneic Graft for Intrabony Periodontal Defects
A study testing Polynucleotide and hyaluronic acid-based gel and Xenogeneic bone graft in people with Periodontitis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Over the last 30 years, the prevalence of periodontitis (PE) has increased substantially, including among younger populations, highlighting the need to improve the management of this condition as a chronic disease and to develop techniques that favor its control and stability in the short and long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Polynucleotide and hyaluronic acid-based gel and Xenogeneic bone graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Feb 2026to May 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age;
- diagnosis of periodontitis stage III or IV, grade B or C (Chapple et al., 2018; Papapanou et al., 2018);
- full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of ≤ 20%;
- presence of a 2- or 3-wall intrabony defect with a depth ≥ 3 mm and probing depth and clinical attachment level ≥ 5 mm in the interproximal region of a single- or multi-rooted tooth;
- pulp vitality or satisfactory endodontic treatment in the tooth to be treated;
- at least 1 mm of keratinized tissue on the buccal surface of the tooth to be treated.
Who cannot join
- presence of furcation involvement associated with the intrabony defect;
- presence of systemic conditions that may affect the progression of periodontitis or the response to its treatment;
- long-term use of anti-inflammatory or immunosuppressive medications;
- use of antimicrobials within the last 6 months;
- continuous use of mouthwashes containing antimicrobial agents within the last 6 months;
- need for prophylactic antibiotic therapy for routine dental procedures;
Show all 9Show fewer
- current or past tobacco use within the last 5 years;
- pregnancy;
- breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Ribeirão Preto School of Dentistry, University of São Paulo
Ribeirão Preto, São Paulo, 14040904
Flavia Furlaneto, +5516 3315-4140, flafurlaneto@usp.br
About this study
Official title: Effects of the Combination of a Polynucleotide and Hyaluronic Acid-Based Gel With Xenogeneic Bone Graft in the Treatment of Intrabony Defects in Patients With Periodontitis: a Randomized Controlled Clinical Trial.
Over the last 30 years, the prevalence of periodontitis (PE) has increased substantially, including among younger populations, highlighting the need to improve the management of this condition as a chronic disease and to develop techniques that favor its control and stability in the short and long term. After non-surgical periodontal therapy (NSPT), the first phase of PE treatment, residual periodontal pockets may persist, often associated with intraosseous defects, which compromise the tooth's prognosis and are associated with disease progression and increased treatment complexity. Surgical treatment of intrabony defects often results in the formation of long junctional epithelium, weakly attached to the root surface, since true regeneration of periodontal tissues is an unpredictable event and depends on complex biological processes. In recent decades, various biomaterials have been proposed as aids to open-flap debridement (OFD) in the surgical treatment of intrabony defects, with the aim of promoting periodontal regeneration, enhancing clinical results and favoring treatment prognosis. Recently, the combination of polynucleotides (PN) and hyaluronic acid (HA) has emerged as a promising auxiliary strategy to promote periodontal regeneration, due to its biological potential in stimulating cell growth and increasing cell viability. The aim of this controlled, randomized, parallel-group clinical study is to compare OFD alone with its association with xenogenous bone graft or xenogenous bone graft plus gel containing PN/HA in the surgical treatment of intrabony defects in patients with PE (stages III or IV, grades B or C). The patients will be randomly divided into three experimental groups (n=22): control (C), xenogeneic bone graft (XENO) and xenogeneic bone graft plus gel containing PN/HA (R-XENO). The patients will receive NSPT, and after eight weeks will undergo surgical procedures to treat the intrabony defects (baseline). Clinical, radiographic, tomographic and immunological periodontal parameters will be assessed at baseline and after 12 months. The wound healing index will be recorded 1, 2 and 6 weeks after the surgical procedure. Patient-centered outcomes will be assessed by means of a visual analog scale (VAS), applied two weeks after the surgical procedure, and oral health-related quality of life (OHRQoL) questionnaires, applied at the beginning of the study and after 6 and 12 months. At the start of the study and after 6 and 12 months, anthropometric data will be collected, blood pressure (BP) will be measured and questionnaires will be applied to survey socio-demographic and nutritional parameters. The data obtained will be statistically analyzed (p<0.05).
Read the detailed description
This controlled, randomized, parallel-group clinical study aims to compare open-flap debridement alone with its association with xenogeneic bone graft or xenogeneic bone graft plus gel containing polynucleotides (PN) and hyaluronic acid (HA) in the surgical treatment of intrabony defects in patients with periodontitis (stages III or IV, grades B or C), based on clinical, immunologic, radiographic/tomographic parameters and patient-centered outcomes.
The sample size was calculated using the primary variable clinical attachment level (CAL), considering a mean difference of 1 mm between the experimental groups as the minimum value and a standard deviation of 0.91. Considering β = 80% and α = 5%, the required sample size was 18 patients for each experimental group, with each patient contributing a single defect. Considering a dropout of 20%, the number was increased to 22 patients per experimental group, making a total of 66 patients.
Patients who meet the inclusion criteria will be randomly assigned to one of three experimental groups (n=22) in a 1:1 allocation ratio: Group C (Control), including intrabony defects treated with open flap debridement alone; Group XENO, including open flap debridement associated with xenogeneic bone grafting; and Group R-XENO, including open flap debridement associated with xenogeneic bone grafting and a PN/HA-containing gel. Randomization will be performed using software, which will identify each participant by a numerical code. Group allocation will be carried out on the day of surgery by the study coordinator.
Surgical treatment: After local anesthesia using an infiltration or nerve block technique with a sterile injectable solution of 2% mepivacaine hydrochloride (20 mg/mL) and 1:100,000 epinephrine (10 µg/mL), intrasulcular incisions will be made on the buccal and lingual/palatal aspects using a 15C surgical blade (Stainless Steel Surgical Blades, Swann-Morton®, Sheffield, England), extending one tooth mesially and one tooth distally to the tooth associated with the defect. A full-thickness flap will be carefully elevated on the buccal and lingual/palatal sides to expose 2 to 3 mm of the alveolar crest. Meticulous debridement of the defect will be performed, along with the removal of subgingival biofilm and calculus using ultrasonic combined with manual instruments, followed by irrigation with sterile saline solution. The defects will be filled as follows: with blood clot only in the group C; with xenogeneic bone graft (Geistlich Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) in the XENO group; and with xenogeneic bone graft (Geistlich Bio-Oss®) plus PN/HA-containing gel (REGENFAST®, Geistlich Pharma AG, Wolhusen, Switzerland) in the R-XENO group. Primary soft tissue closure was achieved by interrupted mattress suture technique with non-resorbable monofilament polyamide 5-0 sutures (Soft Blue®, Techsuture, Bauru, SP, Brazil).
Outcome assessment will be conducted at predefined time points. The primary outcome is clinical attachment level (CAL). Secondary outcomes include probing depth (PD); radiographic and tomographic measures of bone fill and defect resolution; quantitative analysis of biomarkers related to tissue neoformation (PDGF-BB, VEGF, BMP-2); early wound healing assessed by standardized indices; and patient-reported outcomes, including pain perception and oral health-related quality of life.
- Conditions
- Periodontitis
- Being tested
- Polynucleotide and hyaluronic acid-based gel, Control, Xenogeneic bone graft
- Keywords
- Clinical Trial, Periodontitis, Wound Healing, Polynucleotides, Hyaluronic Acid
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polynucleotide and hyaluronic acid-based gelDevice
The polynucleotide and hyaluronic acid-based gel will be applied in combination with a xenogeneic bone graft to fill the intrabony defects.
ControlOther
Intrabony defects treated with open flap debridement alone
Xenogeneic bone graftDevice
The xenogeneic bone graft will be applied to fill the intrabony defects.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Intrabony defects treated with open flap debridement alone Receives: Other: Control |
| XENO | Active comparator | Intrabony defects treated with open flap debridement associated with xenogeneic bone grafting Receives: Device: Xenogeneic bone graft |
| R-XENO | Experimental | Intrabony defects treated with open flap debridement associated with polynucleotide and hyaluronic acid-based gel plus xenogeneic bone grafting Receives: Device: Polynucleotide and hyaluronic acid-based gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level (CAL)
Distance between the cemento-enamel junction and the bottom of the periodontal pocket/sulcus, in milimeters
Measured: Baseline and 12 months
Secondary outcomes (13)
Probing depth (PD)
Distance between the gingival margin and the bottom of the periodontal pocket/sulcus, in milimeters
Measured: Baseline and 12 months
Changes in the alveolar bone crest
Distance between the cemento-enamel junction and the alveolar crest in milimeters, assessed radiographically
Measured: Baseline and 12 months
Radiographic defect depth
Distance between the alveolar crest and the defect base in milimeters, assessed radiographically
Measured: Baseline and 12 months
Vertical bone loss
Distante between the cemento-enamel junction and the defect base in milimeters, assessed radiographically
Measured: Baseline and 12 months
Tomographic vertical bone loss
Distance, in milimeters, between the cemento-enamel junction and the defect base in coronal sections of computed tomography
Measured: Baseline and 12 months
Buccolingual width of the defect
Buccolingual width, in milimeters, assessed in axial sections of computed tomography
Measured: Baseline and 12 months
Platelet-derived growth factor (PDGF)-BB
Quantification in pg/mL using a multiplex assay with Milliplex plates (Millipore)
Measured: Baseline and 12 months
Vascular endothelial growth factor (VEGF)
Quantification in pg/mL using a multiplex assay with Milliplex plates (Millipore)
Measured: Baseline and 12 months
Bone morphogenetic protein (BMP)-2
Quantification in pg/mL using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 12 months
Wound Healing Index (WHI).
A score from 1 to 3 will be assigned according to the following criteria: i) score 1 - uneventful healing, i.e., no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; ii) score 2 - uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; iii) score 3 - poor wound healing, with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Measured: 1, 2 and 6 weeks
Visual Analogue Scale
Patients will complete a questionnaire using a 100 mm visual analogue scale (VAS) , where 0 means no pain/hardship and 100 means unbearable pain/hardship
Measured: 2 weeks
Oral Health Impact Profile (OHIP-14) questionnaire
Oral health-related quality of life assessed using the 14-item Oral Health Impact Profile (OHIP-14) questionnaire. Each item is scored on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is calculated as the sum of all item responses, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life.
Measured: Baseline, 6 and 12 months
Oral Health Related Quality of Life (OHRQoL-UK) questionnaire
Oral health-related quality of life assessed using the Oral Health-Related Quality of Life-UK (OHRQoL-UK) questionnaire. The instrument consists of 16 items covering physical, psychological, and social dimensions. Each item is scored on a 5-point scale ranging from 1 (very bad effect) to 5 (very good effect). The total score is calculated as the sum of all item responses, ranging from 16 to 80, with higher scores indicating better oral health-related quality of life.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start25 Feb 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Model description
- Groups: Patients who meet the inclusion criteria will be randomly assigned to one of three experimental groups (n=22) in a 1:1 allocation ratio: Group C (Control), including intrabony defects treated with open flap debridement alone; Group XENO, including open flap debridement associated with xenogeneic bone grafting; and Group R-XENO, including open flap debridement associated with xenogeneic bone grafting and a PN/HA-containing gel. Randomization will be performed using software, which will identify each participant by a numerical code. Group allocation will be carried out on the day of surgery by the study coordinator.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Flávia Aparecida Chaves Furlaneto, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522684
- Sponsor's protocol ID
- 95039026.0.0000.5419
- Other IDs
- MTA #25-030
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available from the investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Combination of a Polynucleotide and Hyaluronic Acid-Based Gel With Xenogeneic Bone Graft in the Treatment of Intrabony Defects in Patients With Periodontitis: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07522684
- Acronym / sponsor ID
- 95039026.0.0000.5419
- Conditions
- Periodontitis
- Keywords
- Clinical Trial, Periodontitis, Wound Healing, Polynucleotides, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Apr 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.
Over the last 30 years, the prevalence of periodontitis (PE) has increased substantially, including among younger populations, highlighting the need to improve the management of this condition as a chronic disease and to develop techniques that favor its control and stability in the short and long term. After non-surgical periodontal therapy (NSPT), the first phase of PE treatment, residual periodontal pockets may persist, often associated with intraosseous defects, which compromise the tooth's prognosis and are associated with disease progression and increased treatment complexity. Surgical treatment of intrabony defects often results in the formation of long junctional epithelium, weakly attached to the root surface, since true regeneration of periodontal tissues is an unpredictable event and depends on complex biological processes. In recent decades, various biomaterials have been proposed as aids to open-flap debridement (OFD) in the surgical treatment of intrabony defects, with the aim of promoting periodontal regeneration, enhancing clinical results and favoring treatment prognosis. Recently, the combination of polynucleotides (PN) and hyaluronic acid (HA) has emerged as a promising auxiliary strategy to promote periodontal regeneration, due to its biological potential in stimulating cell growth and increasing cell viability. The aim of this controlled, randomized, parallel-group clinical study is to compare OFD alone with its association with xenogenous bone graft or xenogenous bone graft plus gel containing PN/HA in the surgical treatment of intrabony defects in patients with PE (stages III or IV, grades B or C). The patients will be randomly divided into three experimental groups (n=22): control (C), xenogeneic bone graft (XENO) and xenogeneic bone graft plus gel containing PN/HA (R-XENO). The patients will receive NSPT, and after eight weeks will undergo surgical procedures to treat the intrabony defects (baseline). Clinical, radiographic, tomographic and immunological periodontal parameters will be assessed at baseline and after 12 months. The wound healing index will be recorded 1, 2 and 6 weeks after the surgical procedure. Patient-centered outcomes will be assessed by means of a visual analog scale (VAS), applied two weeks after the surgical procedure, and oral health-related quality of life (OHRQoL) questionnaires, applied at the beginning of the study and after 6 and 12 months. At the start of the study and after 6 and 12 months, anthropometric data will be collected, blood pressure (BP) will be measured and questionnaires will be applied to survey socio-demographic and nutritional parameters. The data obtained will be statistically analyzed (p<0.05).
Detailed description
This controlled, randomized, parallel-group clinical study aims to compare open-flap debridement alone with its association with xenogeneic bone graft or xenogeneic bone graft plus gel containing polynucleotides (PN) and hyaluronic acid (HA) in the surgical treatment of intrabony defects in patients with periodontitis (stages III or IV, grades B or C), based on clinical, immunologic, radiographic/tomographic parameters and patient-centered outcomes.
The sample size was calculated using the primary variable clinical attachment level (CAL), considering a mean difference of 1 mm between the experimental groups as the minimum value and a standard deviation of 0.91. Considering β = 80% and α = 5%, the required sample size was 18 patients for each experimental group, with each patient contributing a single defect. Considering a dropout of 20%, the number was increased to 22 patients per experimental group, making a total of 66 patients.
Patients who meet the inclusion criteria will be randomly assigned to one of three experimental groups (n=22) in a 1:1 allocation ratio: Group C (Control), including intrabony defects treated with open flap debridement alone; Group XENO, including open flap debridement associated with xenogeneic bone grafting; and Group R-XENO, including open flap debridement associated with xenogeneic bone grafting and a PN/HA-containing gel. Randomization will be performed using software, which will identify each participant by a numerical code. Group allocation will be carried out on the day of surgery by the study coordinator.
Surgical treatment: After local anesthesia using an infiltration or nerve block technique with a sterile injectable solution of 2% mepivacaine hydrochloride (20 mg/mL) and 1:100,000 epinephrine (10 µg/mL), intrasulcular incisions will be made on the buccal and lingual/palatal aspects using a 15C surgical blade (Stainless Steel Surgical Blades, Swann-Morton®, Sheffield, England), extending one tooth mesially and one tooth distally to the tooth associated with the defect. A full-thickness flap will be carefully elevated on the buccal and lingual/palatal sides to expose 2 to 3 mm of the alveolar crest. Meticulous debridement of the defect will be performed, along with the removal of subgingival biofilm and calculus using ultrasonic combined with manual instruments, followed by irrigation with sterile saline solution. The defects will be filled as follows: with blood clot only in the group C; with xenogeneic bone graft (Geistlich Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) in the XENO group; and with xenogeneic bone graft (Geistlich Bio-Oss®) plus PN/HA-containing gel (REGENFAST®, Geistlich Pharma AG, Wolhusen, Switzerland) in the R-XENO group. Primary soft tissue closure was achieved by interrupted mattress suture technique with non-resorbable monofilament polyamide 5-0 sutures (Soft Blue®, Techsuture, Bauru, SP, Brazil).
Outcome assessment will be conducted at predefined time points. The primary outcome is clinical attachment level (CAL). Secondary outcomes include probing depth (PD); radiographic and tomographic measures of bone fill and defect resolution; quantitative analysis of biomarkers related to tissue neoformation (PDGF-BB, VEGF, BMP-2); early wound healing assessed by standardized indices; and patient-reported outcomes, including pain perception and oral health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Groups: Patients who meet the inclusion criteria will be randomly assigned to one of three experimental groups (n=22) in a 1:1 allocation ratio: Group C (Control), including intrabony defects treated with open flap debridement alone; Group XENO, including open flap debridement associated with xenogeneic bone grafting; and Group R-XENO, including open flap debridement associated with xenogeneic bone grafting and a PN/HA-containing gel. Randomization will be performed using software, which will identify each participant by a numerical code. Group allocation will be carried out on the day of surgery by the study coordinator.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlIntrabony defects treated with open flap debridement alone |
| XENO | Active comparator | Device: Xenogeneic bone graftIntrabony defects treated with open flap debridement associated with xenogeneic bone grafting |
| R-XENO | Experimental | Device: Polynucleotide and hyaluronic acid-based gelIntrabony defects treated with open flap debridement associated with polynucleotide and hyaluronic acid-based gel plus xenogeneic bone grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age;
- diagnosis of periodontitis stage III or IV, grade B or C (Chapple et al., 2018; Papapanou et al., 2018);
- full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of ≤ 20%;
- presence of a 2- or 3-wall intrabony defect with a depth ≥ 3 mm and probing depth and clinical attachment level ≥ 5 mm in the interproximal region of a single- or multi-rooted tooth;
- pulp vitality or satisfactory endodontic treatment in the tooth to be treated;
Key exclusion criteria (9 listed)
- presence of furcation involvement associated with the intrabony defect;
- presence of systemic conditions that may affect the progression of periodontitis or the response to its treatment;
- long-term use of anti-inflammatory or immunosuppressive medications;
- use of antimicrobials within the last 6 months;
- continuous use of mouthwashes containing antimicrobial agents within the last 6 months;
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 |
|---|---|---|
| Polynucleotide and hyaluronic acid-based gelThe polynucleotide and hyaluronic acid-based gel will be applied in combination with a xenogeneic bone graft to fill the intrabony defects. | Device | R-XENO |
| ControlIntrabony defects treated with open flap debridement alone | Other | Control |
| Xenogeneic bone graftThe xenogeneic bone graft will be applied to fill the intrabony defects. | Device | XENO |
Primary outcome
Clinical Attachment Level (CAL)
Time frame: Baseline and 12 months
Distance between the cemento-enamel junction and the bottom of the periodontal pocket/sulcus, in milimeters
13 secondary outcomes
Probing depth (PD)
Time frame: Baseline and 12 months
Changes in the alveolar bone crest
Time frame: Baseline and 12 months
Radiographic defect depth
Time frame: Baseline and 12 months
Vertical bone loss
Time frame: Baseline and 12 months
Tomographic vertical bone loss
Time frame: Baseline and 12 months
Buccolingual width of the defect
Time frame: Baseline and 12 months
Platelet-derived growth factor (PDGF)-BB
Time frame: Baseline and 12 months
Vascular endothelial growth factor (VEGF)
Time frame: Baseline and 12 months
Bone morphogenetic protein (BMP)-2
Time frame: Baseline and 12 months
Wound Healing Index (WHI).
Time frame: 1, 2 and 6 weeks
Visual Analogue Scale
Time frame: 2 weeks
Oral Health Impact Profile (OHIP-14) questionnaire
Time frame: Baseline, 6 and 12 months
Oral Health Related Quality of Life (OHRQoL-UK) questionnaire
Time frame: Baseline, 6 and 12 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 20 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available from the investigator upon reasonable request.
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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.
Ribeirão Preto School of Dentistry, University of São Paulo
Ribeirão Preto, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polynucleotide and hyaluronic acid-based gel and Xenogeneic bone graft in people with Periodontitis, run by University of Sao Paulo at 1 site in Brazil.
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 9 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: looking for participants now, as of the sponsor's last update on 20 Apr 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 Brazil. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (CAL) (time frame: Baseline and 12 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 20 Apr 2026.