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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Site Infection; Periodontal Inflammation; Post-Surgical Complication
• Intervention / Treatment: Other: Periodontal Access Surgery+ Suture with chlorhexidine; Other: Periodontal Access Surgery+ Suture without chlorhexidine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana-María García-De-La-Fuente, phD; Phone Number: 2920 966012000; Email: anamaria.garciad@ehu.eus
• Study Contact Backup: Name: Aitziber Fernández-Jiménez, phD; Phone Number: 2920 966012000; Email: aitziber.fernandez@ehu.eus

Study Locations

• Spain
  • Biscay
    • Leioa, Biscay, Spain, 48940
      • Department fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Country

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: 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.; Other Names: Novosyn Clorhexidine
Active Comparator: Suture without chlorhexidine; At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated without chlorhexidine diacetate (NOVOSYN)	Other: 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 Names: Novosyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-surgical pain	This variable will be collected by means of a questionnaire included in the pain diary (called "UPV/EHU pain diary" Fernández Jiménez et al., 2021).The examiner will record whether the subject has had any regional head and neck pain in the last month prior to the operation and whether any pain was present in the immediate pre-surgical period (last 24 hours). If so, its intensity will be recorded (visual analogue scale (from 0 to 10, where 0 represents no pain and 10 represents the maximum pain known to the subject.	The day of the surgical intervention
Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)	Prior to surgery a Central Sensitization Questionnaire (CSC) will be used (Cuesta-Vargas et al., 2016), in which each subject is asked about the frequency with which they perceive 25 symptoms and will be given a score of 0-4. This will finally establish a clinical level in a range of 0-100 (Subclinical: 0-29 points; Medium: 30-39; Moderate: 40-49; Severe: 50-59; Extreme: 60-100).	Prior to surgery
Post-surgical pain	The subject will be given a pain diary (PD) based on the VAS (Fernández-Jiménez et al., 2021) with instructions for its completion. The subject will be instructed to record their perception of post-surgical pain at 2 and 4 hours, then every 8 hours for the first 3 days and finally daily at the end of the day for a week or until remission. Specifically, the subject will record three variables: the greatest intensity of the pain (0-100), its duration (minutes or hours) and whether any analgesic treatment has been necessary (No or Yes: Which one?). This information will be recorded until the pain has subsided	At 7 days after the surgery
Achievement of primary closure after suturing (in the surgical act).	At each sutured site, the distance between the edges of the incision will be measured with a periodontal probe, being 0 the primary closure and from there we measure the mm of separation.	The day of the surgery
Surgery location information (location of suture, surgery time, surgeon´s experience)	Location of the suture, indicating the teeth between which it is located, as well as the quadrant where it has been performed. Surgery time: Minutes elapsed from the start of anesthesia to the knotting of the last stitch. Surgeon's experience: number of previous periodontal surgeries performed by the surgeon and length of experience measured in months	The day of the surgery
Post-surgical complications (PSCs)	The presence or not of any Post-surgical complications (PSCs) that may occur, as well as their description.	The day of the removal of sutures
Presence of Visible plaque on the suture	Presence of Visible plaque on the suture (dichotomous: yes / no) on the day of stich removal, which will be assessed prior to their removal, noting the value in vestibular, palatal or lingual.	The day of the removal of sutures
Suture looseness	It will be measured in mm with a calibrated periodontal probe, to the nearest 0.5 mm. Prior to cutting the suture, this will be grasped with stitch removal forceps, and the distance from the suture knot to the gingival tissue shall be measured.	The day of the removal of sutures
Pain on suture removal	Pain on suture removal (dichotomous: yes/no) on suture removal, in which we will record whether or not the patient reports discomfort on suture removal.	The day of the removal of sutures
Cytological-histological analysis	The suture of each patient will be analyzed by a) performing cytological smears (Papanicolaou stain) of the material deposited on the suture and b) histologically studying the knot (Included in 10% neutrally buffered formalin solution and later embedded in paraffin. Then, 8 μm thick sections were performed, which were stained with hematoxylin and eosin). Both analyses will be examined under an optical microscope.	The day of the removal of sutures

Collaborators and Investigators

• Sponsor: Ana María García de la Fuente
• Investigators: Study Director: Ana María García-De-La-Fuente, phD, University of the Basque Country (UPV/EHU); Principal Investigator: Aitziber Fernández-Jiménez, phD, University of the Basque Country (UPV/EHU)

Publications and helpful links

General Publications

• 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.
• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
• 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.
• 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.
• 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
• 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.
• 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 record dates

Study Major Dates

• Study Start (Estimated): January 8, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: periodontitis; Surgical site infection; Post-surgical pain; Periodontal surgery; Post-surgical inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Inflammation; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2023/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Not defined
• IPD Sharing Access Criteria: Not defined
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No