Analysis of Early Healing of Sutures in Periodontal Surgery

Официальное название

Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.

Обзор

The main objective is to analyze post-surgical periodontal healing after conventional periodontal surgery where an absorbable suture coated with clorhexidine (Novosyn Clorhexidine) versus conventional sutures without chlorhexidine (Novosyn) will be used a pilot randomized clinical study has been designed. Up to authors´ knowledge until now there are no studies to evaluate periodontal healing after periodontal surgery in combination with this kind of sutures.

Подробное описание

A total of 60 patients will be included, where the unit of study will be each stitch, among the patients attending the Dental Clinic Service of the University of the Basque Country (UPV/EHU) who require surgical periodontal treatment.

The patients will be randomly divided into two groups: the control group using a conventional suture (n=30), and the test group using a suture coated with chlorhexidine diacetate (n=30).

Suture in the control group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate without chlorhexidine (NOVOSYN) Suture in the test group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate and chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE) The primary variable in this study is post-surgical healing in both groups, which will be assessed using the healing index.

Вмешательства

• Другое Periodontal Access Surgery+ Suture with chlorhexidine
  Periodontal conventional surgery will be performed as treatment of periodontal diseases in patients who present active periodontal pockets. At the end of the surgery, the surgeon will suture the flap with the absorbable polyglactin 910 suture coated with chlorhexidine (Novosyn Chlorhexidine). Standardized post-surgical recommendations will be followed.
• Другое Periodontal Access Surgery+ Suture without chlorhexidine
  Periodontal conventional surgery will be performed as treatment of periodontal diseases in patients who present active periodontal pockets. At the end of the surgery, the surgeon will suture the flap with the absorbable polyglactin 910 suture (Novosyn). Standardized post-surgical recommendations will be followed.

Первичные конечные точки

• Periodontal healing index (PQI) (Landry et al., 1988) [Срок оценки: at 7 days, 14 days, 1 month and 2 months after surgery]

Вторичные конечные точки (10)

• Pre-surgical pain [Срок оценки: The day of the surgical intervention]
• Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme) [Срок оценки: Prior to surgery]
• Post-surgical pain [Срок оценки: At 7 days after the surgery]
• Achievement of primary closure after suturing (in the surgical act). [Срок оценки: The day of the surgery]
• Surgery location information (location of suture, surgery time, surgeon´s experience) [Срок оценки: The day of the surgery]
• Post-surgical complications (PSCs) [Срок оценки: The day of the removal of sutures]
• Presence of Visible plaque on the suture [Срок оценки: The day of the removal of sutures]
• Suture looseness [Срок оценки: The day of the removal of sutures]
• Pain on suture removal [Срок оценки: The day of the removal of sutures]
• Cytological-histological analysis [Срок оценки: The day of the removal of sutures]

Критерии участия

Критерии включения

• Patients ≥ 18 years-old
• Patients who have completed the basic periodontal phase and require surgical periodontal treatment for periodontal disease control.
• Plaque index (O'Leary et al.,1972) ≤20%.
• Bleeding index (Ainamo \& Bay,1975) ≤20%.

Критерии исключения

• Patients with systemic conditions contraindicating surgery
• Patients with allergy to chlorhexidine and/or o-cymen-5-ol
• Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
• Pregnant or breastfeeding women
• Patients with periodontal defects requiring regenerative surgery or mucogingival surgery/periodontal plastic therapy
• Patients who have taken antibiotics in the last 3months

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Диагностика

Центры проведения

Испания · 1 центр

• Department fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Count — Leioa

Публикации

• Landry RG, Turnbull RS, Howley T. Effectiveness of benzydamine HCl in the treatment of periodontal postsurgical patients. Research in Clinic Forums 1988;10:105-118
• Cuesta-Vargas AI, Roldan-Jimenez C, Neblett R, Gatchel RJ. Cross-cultural adaptation and validity of the Spanish central sensitization inventory. Springerplus. 2016 Oct 21;5(1):1837. doi: 10.1186/s40064-016-3515-4. eCollection 2016. PMID 27818875
• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35. PMID 1058834
• Dragovic M, Pejovic M, Stepic J, Colic S, Dozic B, Dragovic S, Lazarevic M, Nikolic N, Milasin J, Milicic B. Comparison of four different suture materials in respect to oral wound healing, microbial colonization, tissue reaction and clinical features-randomized clinical study. Clin Oral Investig. 2020 Apr;24(4):1527-1541. doi: 10.1007/s00784-019-03034-4. Epub 2019 Jul 24. PMID 31342245
• Fernandez-Jimenez A, Estefania-Fresco R, Garcia-De-La-Fuente AM, Marichalar-Mendia X, Aguirre-Zorzano LA. Description of the modified vestibular incision subperiosteal tunnel access (m-VISTA) technique in the treatment of multiple Miller class III gingival recessions: a case series. BMC Oral Health. 2021 Mar 20;21(1):142. doi: 10.1186/s12903-021-01511-5. PMID 33743644
• Ford HR, Jones P, Gaines B, Reblock K, Simpkins DL. Intraoperative handling and wound healing: controlled clinical trial comparing coated VICRYL plus antibacterial suture (coated polyglactin 910 suture with triclosan) with coated VICRYL suture (coated polyglactin 910 suture). Surg Infect (Larchmt). 2005 Fall;6(3):313-21. doi: 10.1089/sur.2005.6.313. PMID 16201941
• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available. PMID 4500182
• Tae BS, Park JH, Kim JK, Ku JH, Kwak C, Kim HH, Jeong CW. Comparison of intraoperative handling and wound healing between (NEOSORB(R) plus) and coated polyglactin 910 suture (NEOSORB(R)): a prospective, single-blind, randomized controlled trial. BMC Surg. 2018 Jul 6;18(1):45. doi: 10.1186/s12893-018-0377-4. PMID 29980202

Идентификаторы

NCT: NCT06201377 · 2023/01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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