Periodontal Inflammation, Post-Surgical Complication, Surgical Site Infection
Conditions
Keywords
Surgical site infection, Periodontal surgery, Post-surgical pain, Post-surgical inflammation, periodontitis
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.
Interventions
OTHERPeriodontal 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.
OTHERPeriodontal 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.
Sponsors
Ana María García de la Fuente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal healing index (PQI) (Landry et al., 1988) | at 7 days, 14 days, 1 month and 2 months after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme) | Prior to surgery | 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). |
| Post-surgical pain | At 7 days after the surgery | 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 |
| Achievement of primary closure after suturing (in the surgical act). | The day of the surgery | 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. |
| Surgery location information (location of suture, surgery time, surgeon´s experience) | The day of the surgery | 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 |
| Pre-surgical pain | The day of the surgical intervention | 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. |
| Presence of Visible plaque on the suture | The day of the removal of sutures | 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. |
| Suture looseness | The day of the removal of sutures | 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. |
| Pain on suture removal | The day of the removal of sutures | 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. |
| Cytological-histological analysis | The day of the removal of sutures | 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. |
| Post-surgical complications (PSCs) | The day of the removal of sutures | The presence or not of any Post-surgical complications (PSCs) that may occur, as well as their description. |
Countries
Spain
Outcome results
None listed