An interventional study of Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application and Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application in Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use and Alveolar Bone Loss* / Therapy, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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:
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:
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.
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 60 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application
Procedure: Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application
Procedure: Flapless instrumentation of the defect and product application simulation
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.
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.
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.
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).
Time frame: Baseline, 6 and 12 months.
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.
Time frame: Baseline, 6 and 12 months.
Gingival recession
Distance (mm) between the CEJ and the gingival margin.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 12 months after baseline (regenerative intervention)
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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