Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application
  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
• Процедура Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application
  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
• Процедура Flapless instrumentation of the defect and product application simulation
  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.

Первичные конечные точки

• Radiographic bone fill [Срок оценки: Baseline, 6 and 12 months.]

Вторичные конечные точки (11)

• Clinical attachment level (CAL) gain [Срок оценки: Baseline, 6 and 12 months.]
• Gingival recession [Срок оценки: Baseline, 6 and 12 months.]
• Probing pocket depth (PD) [Срок оценки: Baseline,6 and 12 months.]
• Bleeding on probing [Срок оценки: Baseline, 6 and 12 months.]
• Plaque index [Срок оценки: Baseline, 6 and 12 months.]
• Chair time [Срок оценки: During procedure]
• Patient satisfaction and perception [Срок оценки: 1 week after baseline (regenerative intervention)]
• Patient satisfaction and perception [Срок оценки: 1 week after baseline (regenerative intervention)]
• Patient satisfaction and perception [Срок оценки: 1 week after baseline (regenerative intervention)]
• Patient satisfaction and perception [Срок оценки: 6 months after baseline (regenerative intervention)]
• Patient satisfaction and perception [Срок оценки: 12 months after baseline (regenerative intervention)]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Clínica Odontológica de la Universidad de Valencia — Valencia

Публикации

• 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. PMID 2738832
• Tonetti 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. PMID 15560811
• Anoixiadou 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. PMID 34708441
• Anoixiadou 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. PMID 36661562

Идентификаторы

NCT: NCT07339605 · 2023-ODON-3018356

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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