NCT06201377|UnknownDMC
Analysis of Early Healing of Sutures in Periodontal Surgery
Sutures
Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.
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Sutures
Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.
Sponsor study identifier
interventional
60
1 country
1
Study Start
January 8, 2024
Actual (reported)Primary Completion
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2023
Actual (reported)January 8, 2024
Actual (reported)January 11, 2024
Actual (reported)January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Periodontal healing index (PQI) (Landry et al., 1988)
This periodontal healing index was described by Landy et al. in 1988. The index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). The index will be from 1 to 5, where point 1 was defined as "healing way scarce" and point 5 such as "excellent healing" (Landry RG, Turnbull RS, Howley T. Effectiveness of benzydamine HCL in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988; 10:105-118)
at 7 days, 14 days, 1 month and 2 months after surgery
Pre-surgical pain
The day of the surgical intervention
At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated with chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE)
At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated without chlorhexidine diacetate (NOVOSYN)
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment and procedure
Periodontal Access Surgery+ Suture with chlorhexidine
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordDepartment fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, 48940, Spain
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.
Ana María García-De-La-Fuente, phD
University of the Basque Country (UPV/EHU)
Aitziber Fernández-Jiménez, phD
University of the Basque Country (UPV/EHU)
First Submitted
December 30, 2023
First Posted
January 11, 2024
Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)
Prior to surgery
Post-surgical pain
At 7 days after the surgery
Achievement of primary closure after suturing (in the surgical act).
The day of the surgery
Surgery location information (location of suture, surgery time, surgeon´s experience)
The day of the surgery
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Study Start
January 8, 2024
Actual (reported)Primary Completion
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 7, 2024
Record last verified: 2024-08
A code will identify the data collected for the study and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number (ENFERMEDADES PERIODONTALES Y PERIIMPLANTARIAS/01/2023; TI0573) whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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