Guided Tissue Regeneration, Periodontal / MethodsNCT07339605
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
A study testing Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application, Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application and Flapless instrumentation of the defect and product application simulation in people with Guided Tissue Regeneration, Periodontal / Methods and Dental Enamel Proteins* / Therapeutic Use, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use, Alveolar Bone Loss* / Therapy
- What is being tested?
- Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application, Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application and Flapless instrumentation of the defect and product application simulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2024to Jul 2027
- 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
- Periodontitis stage III or IV, grade A or B (Tonetti et al., 2017): attachment loss ≥ 5mm, radiographic bone loss extending to to the middle third and beyond, tooth loss ≥4 due to periodontitis, probing depth (PD) ≥ 6mm.
- Older adults ≥ 18 years. The number per sex shall be balanced.
- Plaque index (PI) < 1 following initial periodontal therapy and hygiene instructions.
- Bleeding on probing (BoP) ≤ 10%.
- Only patients with optimal compliance, assessed during etiological therapy, will be selected.
- At least a 2-3 wall interproximal bone defect with a radiographically moderate or deep intrabony defect (≥3mm), PD≥ 6mm using a Williams probe on uniradicular teeth or mandibular molars without furcation involvement after non-surgical periodontal treatment.
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- Vital teeth or teeth with well-performed root canal treatment.
- Absence of caries, prosthetic restoration or periapical infection in the tooth to be regenerated.
- Absence of systemic pathology.
- Negative history of pregnancy.
- Signed informed consent.
- The participant is willing and able to comply with the necessary visits for the treatments and evaluations scheduled during the clinical study.
Who cannot join
- The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.
- Smoking ≥10 cigarettes/day.
- Daily alcohol intake > 4U.
- Chronic illness or reduced mental capacity that may influence compliance with the protocol.
- Medications or drugs that alter the patient's healing or with concomitant oral manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
- Systemic diseases that may influence treatment such as diabetes mellitus or rheumatoid disease.
Show all 9Show fewer
- Allergies to drug compounds.
- Antibiotic intake 3 months prior to the start of the study or systemic condition requiring antibiotic coverage at the time of periodontal treatment.
- Periodontal treatment 6 months prior to the start of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clínica Odontológica de la Universidad de Valencia
Valencia, Valencia, 46010
Ferran Sánchez Benito, +34646411370, sanbefe@alumni.uv.es
About this study
Official title: Clinical and Radiographic Outcomes After Flapless Approach of Intrabony Defects With the Application of Enamel Matrix Derivative Versus Hyaluronic Acid: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and enamel matrix derivative (EMD, Emdogain® FL) in periodontal regeneration. The main questions it aims to answer are:
- ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative?
- ¿What is the patient perception and satisfaction with the received treatment?
Read more
Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product).
The sample will be distributed according to the following treatments:
- Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®.
- Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL.
- Control group: SRP, MINST without any bioactive product.
Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C.
After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.
- Conditions
- Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use, Alveolar Bone Loss* / Therapy, Hyaluronic Acid* / Therapeutic Use, Humans, Intrabony Defect
- Being tested
- Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application, Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application, Flapless instrumentation of the defect and product application simulation
- Keywords
- Periodontitis, Intrabony defect, Hyaluronic acid, Enamel matrix derivative, Periodontal regeneration
- Medical subject headings
- Alveolar Bone Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid applicationProcedure or surgery
The NaOCL gel buffered with amino acids will be carefully injected and maintained for 60 seconds. Following this, pocket debridement will be carried out following the MINST technique. In order to allow for optimal root visualization and gain access to the intrabony defect, a microsurgical dental mirror will be used in conjunction with an atraumatic gingival retractor for a gentle lateral papilla displacement. Teeth will be instrumented until no residual calculus could be detected after a careful root evaluation with a periodontal explorer and no debris or biofilm flushed out of the pocket after irrigation. If this does not occur, the application of NaOCL, instrumentation and saline solution rinse shall be repeated until this is achieved. After irrigation, sterile gauze will be placed in the vestibule in the proximity of a selected site and a thorough drying of the site will be perfomed with air-spray. HA will be applied with a blunt tipped sterile syringe, until overflowing.
Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD applicationProcedure or surgery
Subgingival instrumentation will be performed following the MINST technique in conjunction with a microsurgical dental mirror and an atraumatic gingival retractor without applying any product previously. Teeth will be instrumented until no residual calculus could be detected and no debris or biofilm flushed out of the pocket after irrigation with sterile saline solution. Following this, it will be dried and the root will be conditioned applying EDTA with a thin blunt tip for 2 minutes to remove the dentin mud layer from the root surfaces. Subsequently, the defect area will be carefully rinsed with water-spray and by 5-s passage of ultrasonic instrument's fine tip in the site with no contact to the root surface. A sterile gauze will be placed in the vestibule in the proximity of a selected site and a thorough drying of the site will be performed with an air-spray. Once bleeding control is achieved, EMD will be applied with a blunt tipped sterile syringe (25G), until overflowing.
Flapless instrumentation of the defect and product application simulationProcedure or surgery
Subgingival instrumentation will be performed following MINST and EDT+EMD or NaOCl+HA application will be simulated by inserting the manufacturer's syringes within the pocket, but the defects won't receive any adjunct.
| Study group | Role | What they receive |
|---|---|---|
| (MINST + NaOCl) + HA | Experimental | Not described Receives: Procedure: Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application |
| (MINST + EDTA) + EMD | Active comparator | Not described Receives: Procedure: Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application |
| MINST | Sham comparator | Not described Receives: Procedure: Flapless instrumentation of the defect and product application simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone fill
Depth of the intraosseous defect (B - D); and following the healing period (X - C).
Bone fill (BF) will be calculated by subtracting the (X - C) measurement recorded at the 6-month and 12-month postoperative review from the depth recorded before the regenerative intervention (B - D).
Measured: Baseline, 6 and 12 months.
Secondary outcomes (11)
Clinical attachment level (CAL) gain
CAL is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the CAL before the intervention and after the intervention will be carried out.
Measured: Baseline, 6 and 12 months.
Gingival recession
Distance (mm) between the CEJ and the gingival margin.
Measured: Baseline, 6 and 12 months.
Probing pocket depth (PD)
The probing depth will be measured in six areas (disto-buccal, mediate-vestibular, mesio-buccal, disto-palatal, mid-palatal, and mesio-palatal) of each tooth with a Williams PQ-OW 208 396 probe. It will be use with a pressure of 20 grams that is equivalent to the pressure of dropping the weight of the probe without exerting additional pressu
Measured: Baseline,6 and 12 months.
Bleeding on probing
The "Full mouth bleeding score" (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing depths are checked. The usual thing is to measure 4 points for each tooth, but the investigators have modified the index and value 6 points per tooth (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio-palatal).
The investigators consider that the score is 1 when there is a red dot in the bleeding diagram of the periodontogram and 0 when there is a blank box.
Measured: Baseline, 6 and 12 months.
Plaque index
The plaque will be quantified as follows:
Score 0 = no plaque Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth.
Score 2 = Moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen without magnification.
Score 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin.
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
Measured: Baseline, 6 and 12 months.
Chair time
The duration of the procedure will be timed, starting with the application of local anaesthesia and ending after the application of the bioactive material.
Measured: During procedure
Patient satisfaction and perception
- The presence or absence of bleeding, swelling, suppuration, tooth hypersensitivity and interference with daily activities will be assessed by dichotomous question. In case of a positive answer, 5-point Likert scale will be used (far too little, too little, about right, too much, far too much).
Measured: 1 week after baseline (regenerative intervention)
Patient satisfaction and perception
Visual analog scale (VAS) will be used to evaluate the intensity of the discomfort and pain (Mounssif and cols., 2023). It consists of a horizontal line of 100 millimeters, with the extreme expressions of a symptom at each end. The left end represents absence or lower intensity, while the right end represents the highest intensity (Tonetti and cols., 2004). Patients are asked to mark on the line the point that indicates the intensity, and it is measured with a millimeter ruler. The intensity is expressed in millimeters. The assessment will be:
- Mild pain if the patient scores pain as less than 30.
- Moderate pain if the rating is between 40 and 70.
- Severe pain if the rating is 80 or higher.
Measured: 1 week after baseline (regenerative intervention)
Patient satisfaction and perception
- Oral health impact profile (OHIP-14, Spanish version). The OHIP-14 scores can range from 0 to 56 and are calculated by adding the ordinal values for each of the 14 domains. Scores for individual domains can range from 0 to 5 (Montero-Martín and cols., 2009).
Measured: 1 week after baseline (regenerative intervention)
Patient satisfaction and perception
Patients will be asked to describe their perception of the outcome in terms of improvement in gingival bleeding, redness, gingival swelling, and hygiene capability. These parameters will also be measured using a Visual Analog Scale (VAS), where zero indicates no improvement and 100 indicates maximum improvement.
Measured: 6 months after baseline (regenerative intervention)
Patient satisfaction and perception
Finally, the perception and satisfaction level with the aesthetic result of the treatment will be evaluated by selecting one of the following options: very satisfied, satisfied, neutral, moderately satisfied, or dissatisfied (Wismeyer and cols., 1995).
Measured: 12 months after baseline (regenerative intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start26 Oct 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Guided Tissue Regeneration, Periodontal / MethodsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Lopez Roldan, University of Valencia
- Investigators
- Andrés López Roldán, Study director, University of ValenciaJosé Manuel Almerich Silla, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339605
- Sponsor's protocol ID
- 2023-ODON-3018356
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Steffensen B, Webert HP. Relationship between the radiographic periodontal defect angle and healing after treatment. J Periodontol. 1989 May;60(5):248-54. doi: 10.1902/jop.1989.60.5.248.
PubMed 2738832Tonetti MS, Fourmousis I, Suvan J, Cortellini P, Bragger U, Lang NP; European Research Group on Periodontology (ERGOPERIO). Healing, post-operative morbidity and patient perception of outcomes following regenerative therapy of deep intrabony defects. J Clin Periodontol. 2004 Dec;31(12):1092-8. doi: 10.1111/j.1600-051X.2004.00615.x.
PubMed 15560811Anoixiadou S, Parashis A, Vouros I. Enamel matrix derivative as an adjunct to minimally invasive non-surgical treatment of intrabony defects: A randomized clinical trial. J Clin Periodontol. 2022 Feb;49(2):134-143. doi: 10.1111/jcpe.13567. Epub 2021 Nov 9.
PubMed 34708441Anoixiadou S, Parashis A, Vouros I. Minimally Invasive Non-Surgical Technique in the Treatment of Intrabony Defects-A Narrative Review. Dent J (Basel). 2023 Jan 11;11(1):25. doi: 10.3390/dj11010025.
PubMed 36661562
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes After Flapless Approach of Intrabony Defects With the Application of Enamel Matrix Derivative Versus Hyaluronic Acid: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07339605
- Acronym / sponsor ID
- 2023-ODON-3018356
- Conditions
- Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use, Alveolar Bone Loss* / Therapy, Hyaluronic Acid* / Therapeutic Use, Humans, Intrabony Defect
- Keywords
- Periodontitis, Intrabony defect, Hyaluronic acid, Enamel matrix derivative, Periodontal regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Jan 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.
The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and enamel matrix derivative (EMD, Emdogain® FL) in periodontal regeneration. The main questions it aims to answer are:
- ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative?
- ¿What is the patient perception and satisfaction with the received treatment?
Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product).
The sample will be distributed according to the following treatments:
- Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®.
- Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL.
- Control group: SRP, MINST without any bioactive product.
Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C.
After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (MINST + NaOCl) + HA | Experimental | Procedure: Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application |
| (MINST + EDTA) + EMD | Active comparator | Procedure: Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application |
| MINST | Sham comparator | Procedure: Flapless instrumentation of the defect and product application simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Periodontitis stage III or IV, grade A or B (Tonetti et al., 2017): attachment loss ≥ 5mm, radiographic bone loss extending to to the middle third and beyond, tooth loss ≥4 due to periodontitis, probing depth (PD) ≥ 6mm.
- Older adults ≥ 18 years. The number per sex shall be balanced.
- Plaque index (PI) < 1 following initial periodontal therapy and hygiene instructions.
- Bleeding on probing (BoP) ≤ 10%.
- Only patients with optimal compliance, assessed during etiological therapy, will be selected.
Key exclusion criteria (9 listed)
- The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.
- Smoking ≥10 cigarettes/day.
- Daily alcohol intake > 4U.
- Chronic illness or reduced mental capacity that may influence compliance with the protocol.
- Medications or drugs that alter the patient's healing or with concomitant oral manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
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 |
|---|---|---|
| Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid applicationThe NaOCL gel buffered with amino acids will be carefully injected and maintained for 60 seconds. Following this, pocket debridement will be carried out following the MINST technique. In order to allow for optimal root visualization and gain access to the intrabony defect, a microsurgical dental mirror will be used in conjunction with an atraumatic gingival retractor for a gentle lateral papilla displacement. Teeth will be instrumented until no residual calculus could be detected after a careful root evaluation with a periodontal explorer and no debris or biofilm flushed out of the pocket after irrigation. If this does not occur, the application of NaOCL, instrumentation and saline solution rinse shall be repeated until this is achieved. After irrigation, sterile gauze will be placed in the vestibule in the proximity of a selected site and a thorough drying of the site will be perfomed with air-spray. HA will be applied with a blunt tipped sterile syringe, until overflowing. | Procedure or surgery | (MINST + NaOCl) + HA |
| Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD applicationSubgingival instrumentation will be performed following the MINST technique in conjunction with a microsurgical dental mirror and an atraumatic gingival retractor without applying any product previously. Teeth will be instrumented until no residual calculus could be detected and no debris or biofilm flushed out of the pocket after irrigation with sterile saline solution. Following this, it will be dried and the root will be conditioned applying EDTA with a thin blunt tip for 2 minutes to remove the dentin mud layer from the root surfaces. Subsequently, the defect area will be carefully rinsed with water-spray and by 5-s passage of ultrasonic instrument's fine tip in the site with no contact to the root surface. A sterile gauze will be placed in the vestibule in the proximity of a selected site and a thorough drying of the site will be performed with an air-spray. Once bleeding control is achieved, EMD will be applied with a blunt tipped sterile syringe (25G), until overflowing. | Procedure or surgery | (MINST + EDTA) + EMD |
| Flapless instrumentation of the defect and product application simulationSubgingival instrumentation will be performed following MINST and EDT+EMD or NaOCl+HA application will be simulated by inserting the manufacturer's syringes within the pocket, but the defects won't receive any adjunct. | Procedure or surgery | MINST |
Primary outcome
Radiographic bone fill
Time frame: Baseline, 6 and 12 months.
Depth of the intraosseous defect (B - D); and following the healing period (X - C). Bone fill (BF) will be calculated by subtracting the (X - C) measurement recorded at the 6-month and 12-month postoperative review from the depth recorded before the regenerative intervention (B - D).
11 secondary outcomes
Clinical attachment level (CAL) gain
Time frame: Baseline, 6 and 12 months.
Gingival recession
Time frame: Baseline, 6 and 12 months.
Probing pocket depth (PD)
Time frame: Baseline,6 and 12 months.
Bleeding on probing
Time frame: Baseline, 6 and 12 months.
Plaque index
Time frame: Baseline, 6 and 12 months.
Chair time
Time frame: During procedure
Patient satisfaction and perception
Time frame: 1 week after baseline (regenerative intervention)
Patient satisfaction and perception
Time frame: 1 week after baseline (regenerative intervention)
Patient satisfaction and perception
Time frame: 1 week after baseline (regenerative intervention)
Patient satisfaction and perception
Time frame: 6 months after baseline (regenerative intervention)
Patient satisfaction and perception
Time frame: 12 months after baseline (regenerative intervention)
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 19 Aug 2026.
- Background: PubMed 2738832Steffensen B, Webert HP. Relationship between the radiographic periodontal defect angle and healing after treatment. J Periodontol. 1989 May;60(5):248-54. doi: 10.1902/jop.1989.60.5.248.
- Background: PubMed 15560811Tonetti MS, Fourmousis I, Suvan J, Cortellini P, Bragger U, Lang NP; European Research Group on Periodontology (ERGOPERIO). Healing, post-operative morbidity and patient perception of outcomes following regenerative therapy of deep intrabony defects. J Clin Periodontol. 2004 Dec;31(12):1092-8. doi: 10.1111/j.1600-051X.2004.00615.x.
- Background: PubMed 34708441Anoixiadou S, Parashis A, Vouros I. Enamel matrix derivative as an adjunct to minimally invasive non-surgical treatment of intrabony defects: A randomized clinical trial. J Clin Periodontol. 2022 Feb;49(2):134-143. doi: 10.1111/jcpe.13567. Epub 2021 Nov 9.
- Background: PubMed 36661562Anoixiadou S, Parashis A, Vouros I. Minimally Invasive Non-Surgical Technique in the Treatment of Intrabony Defects-A Narrative Review. Dent J (Basel). 2023 Jan 11;11(1):25. doi: 10.3390/dj11010025.
- Individual participant dataSharing planned: Yes
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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.
Andrés López Roldán study director
University of Valencia
José Manuel Almerich Silla study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application, Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application and Flapless instrumentation of the defect and product application simulation in people with Guided Tissue Regeneration, Periodontal / Methods and Dental Enamel Proteins* / Therapeutic Use, run by University of Valencia at 1 site in Spain.
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 12 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 19 Aug 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 Spain. 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.
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 Ferran Sánchez Benito (+34646411370, sanbefe@alumni.uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic bone fill (time frame: Baseline, 6 and 12 months.). 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 NCT07339605, which also lists 4 linked publications.
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 19 Aug 2026.