Analysis of Early Healing of Sutures in Periodontal Surgery

NCT06201377 | Enrolling By Invitation DMC

• 1 other identifier: 2023/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Surgical Complication; Periodontal Inflammation; Surgical Site Infection

Keywords

Surgical site infection; Periodontal surgery; Post-surgical pain; Post-surgical inflammation; periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pre-surgical pain

  The day of the surgical intervention

• 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

Study Arms (2)

Suture with chlorhexidine

EXPERIMENTAL

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

Suture without chlorhexidine

ACTIVE COMPARATOR

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

Interventions

Periodontal Access Surgery+ Suture with chlorhexidine OTHER

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.

Also known as: Novosyn Clorhexidine

Suture with chlorhexidine

Periodontal Access Surgery+ Suture without chlorhexidine OTHER

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.

Also known as: Novosyn

Suture without chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ana María García de la Fuente: lead

Study Sites (1)

Department fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Country

Leioa, Biscay, 48940, Spain

Location

Related Publications (8)

• 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

  BACKGROUND

• 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 BACKGROUND

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

  PMID: 1058834 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Pain, Postoperative; Periodontitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ana María García-De-La-Fuente, phD

  University of the Basque Country (UPV/EHU)

  STUDY DIRECTOR

• Aitziber Fernández-Jiménez, phD

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant: Initially, the subject will not know which suture he/she has received, full information regarding the suture used, as well as the results obtained in his/her case, will be given at the last visit of the study. 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: We will perform the experimental (periodontal surgery where the suture of the flap will be an absorbable suture with clorhexidine) control technique (periodontal surgery where the suture of the flap will be an absorbable suture without clorhexidine) according to the randomization sequence.

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: January 8, 2024
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Not defined
• Access Criteria: Not defined

Locations

ES (1)