Clinical trial NCT06201377: Analysis of Early Healing of Sutures in Periodontal Surgery
Official title: Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post-Surgical Complication
Periodontal Inflammation
Surgical Site Infection
Keywords: Surgical site infection
Periodontal surgery
Post-surgical pain
Post-surgical inflammation
periodontitis
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Periodontal healing index (PQI) (Landry et al., 1988)
timeFrame: at 7 days, 14 days, 1 month and 2 months after surgery
Secondary outcomes:
measure: Pre-surgical pain
timeFrame: The day of the surgical intervention
measure: Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)
timeFrame: Prior to surgery
measure: Post-surgical pain
timeFrame: At 7 days after the surgery
measure: Achievement of primary closure after suturing (in the surgical act).
timeFrame: The day of the surgery
measure: Surgery location information (location of suture, surgery time, surgeon´s experience)
timeFrame: The day of the surgery
measure: Post-surgical complications (PSCs)
timeFrame: The day of the removal of sutures
measure: Presence of Visible plaque on the suture
timeFrame: The day of the removal of sutures
measure: Suture looseness
timeFrame: The day of the removal of sutures
measure: Pain on suture removal
timeFrame: The day of the removal of sutures
measure: Cytological-histological analysis
timeFrame: The day of the removal of sutures
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Department fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Country
state: Biscay
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Ana María García-De-La-Fuente, phD
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Aitziber Fernández-Jiménez, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.