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क्लिनिकल ट्रायल NCT07501585 के लिए पेरिअपिकल पेरियोडोंटाइटिस वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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कार्ड दृश्य

Hyaluronic Acid in Endodontic Microsurgery 46 रैंडमाइज़्ड

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07501585 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो पेरिअपिकल पेरियोडोंटाइटिस से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 20 फ़रवरी 2026 को हुई थी, और इसमें कुल 46 प्रतिभागियों के नामांकन की योजना है। बर्न विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 30 मार्च 2026 को अंतिम बार अपडेट की गई थी
संक्षिप्त सारांश
This randomized clinical trial (RCT) will evaluate the effectiveness of cross-linked hyaluronic acid as an adjunct to endodontic microsurgery in adult patients with apical periodontitis affecting maxillary or mandibular first molars. Participants previously treated with non-surgical endodontic therapy will be allocated to either endodontic microsurgery with cross-linked hyaluronic acid application (test group) or the...और दिखाएँ
विस्तृत विवरण
Background and Rationale:

Endodontic microsurgery is an established treatment for persistent apical periodontitis after non-surgical root canal treatment. Successful healing depends on appropriate surgical technique, infection control, and favorable soft and hard tissue regeneration. Cross-linked hyaluronic acid is a non-animal-origin biomaterial with hydrating, tissue-supportive, and bacteriostatic properties, and ...

और दिखाएँ
आधिकारिक शीर्षक

Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery. A RCT

स्वास्थ्य स्थितियां
पेरिअपिकल पेरियोडोंटाइटिस
अन्य अध्ययन आईडी
  • HA in endo surgery
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-02-20
अंतिम अद्यतन प्रकाशित
2026-03-30
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-12-31
नामांकन (अनुमानित)
46
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
Endodontic microsurgery
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकTest: endodontic microsurgery with hyaluronic acid
The endodontic microsurgery will be performed, then cross-linked hyaluronic acid will be added in the surgical area.
हयालूरोनिक एसिड
The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be...और दिखाएँ
एंडोडोंटिक माइक्रोसर्जरी
The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be...और दिखाएँ
सक्रिय तुलना समूहControl: mere endodontic microsurgery
Endodontic microsurgery will be performed only.
एंडोडोंटिक माइक्रोसर्जरी
The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be...और दिखाएँ
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
The healing of soft tissues will be evaluated by the Early wound healing score
The early wound healing index assesses periodontal soft tissue healing, usually around 1 week post-surgery, by evaluating flap closure, fibrin presence, and necrosis in 5 grades. It ranges from score 1 (complete healing) to score 5 (necrosis and pus)
4 days after surgery
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
The postoperative pain will be evaluated by visual analogue scale VAS
The visual analogue scale is a mm scale from 0 (no pain) to 100 mm (maximal possible pain)
within the two first weeks after surgery
Periapical healing assessed on periapical radiographs according to the Molven's criteria
The Molven's criteria is a 2D radiographic classification system used to evaluate the healing outcome of apical endodontic surgery, four main categories exist: Complete Healing: Bone tissue is completely restored, and a normal periodontal ligament (PDL) space is visible. Incomplete Healing (Scar Tissue): The initial radiolucent area has reduced in size, but a small residual rarefaction remains, often characterized as a "scar". Uncertain Healing: A reduction in the size of the lesion has occurred, but it does not fit the criteria for complete or incomplete healing. Unsatisfactory Healing (Failures): The radiolucent lesion is unchanged, has increased in size, or appears newly developed, indicating failure.
3, 6, and 12 months post-surgery
Pericapial healing on cone beam computed tomography (CBCT) scans according to PENN's criteria
Healing of endodontic microsurgery assessed using CBCT imaging, categories: Complete Healing (Success): Full bone repair, with the periodontal space having a normal width. Limited Healing (Success): Bone regeneration, but the periodontal space over the resected root surface is slightly widened (but less than twice the width of non-involved root). Uncertain Healing (Failure): A small defect or continued radiolucency persists in the lamina dura around the root-end filling. Unsatisfactory Healing (Failure): No change or an increase in the size of the radiolucent area, with poor bone repair.
6 and 12 months post-surgery
Cortical plate healing
Cortical plate healing will be scored according to the RAC/B index: Score 0: Cortical plate not re-established. Score 1: Cortical plate is partially re-established. Score 2: Cortical plate is re-established
6 and 12 months post-surgery
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
  • Written informed consent
  • ≥18 years of age
  • Apical peridontitis at maxillar or mandibular first molars ≥ 12 months after non-surgical endodontical treatment
  • Full mouth plaque score (FMPS) and bleeding score (BoP) < or 20%
  • Periapical lesion < or 10 mm
  • Four-wall bone defect morphology

  • Smokers of more than 10 cigarettes a day
  • Allergy to hyaluronic acid
  • Pregnancy or lactation
  • Uncontrolled Diabetes
  • Untreated periodontal conditions
  • Any conditions associated with poor compliance or failure to maintain good oral hygiene
  • Acute infections lesions in areas intended for surgery
  • Chemotherapy and radiotherapy treatment
अध्ययन केंद्रीय संपर्क
संपर्क: Anton Sculean, Prof., +41316840620, [email protected]
संपर्क: Vitaly Fuog, DMD, +41795378238, [email protected]
1 1 देशों में अध्ययन स्थान
Praktika 1, Moscow, 127006, Russia
Anton Sculean, Prof, संपर्क, +41316840620, [email protected]
Alexandra Stähli, PD, संपर्क, +41316840620, [email protected]
भर्ती जारी