Analysis of Early Healing of Sutures in Periodontal Surgery
NCT ID: NCT06201377
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
60 participants
INTERVENTIONAL
2024-01-08
2025-06-30
Brief Summary
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Up to authors´ knowledge until now there are no studies to evaluate periodontal healing after periodontal surgery in combination with this kind of sutures.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Observer: (R.E. Another periodontist, external to the intervention, will be in charge of recording the clinical parameters.) Analyst: (X. M. The statistician does not know to which treatment each variable corresponds.
Study Groups
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Suture with chlorhexidine
At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated with chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE)
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.
Suture without chlorhexidine
At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated without chlorhexidine diacetate (NOVOSYN)
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Ana María García de la Fuente
OTHER
Responsible Party
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Ana María García de la Fuente
Professor
Principal Investigators
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Ana María García-De-La-Fuente, phD
Role: STUDY_DIRECTOR
University of the Basque Country (UPV/EHU)
Aitziber Fernández-Jiménez, phD
Role: PRINCIPAL_INVESTIGATOR
University of the Basque Country (UPV/EHU)
Locations
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Department fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, Spain
Countries
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References
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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.
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
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.
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.
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.
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.
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.
Other Identifiers
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2023/01
Identifier Type: -
Identifier Source: org_study_id
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