An interventional study of Periodontal Access Surgery+ Suture with chlorhexidine and Periodontal Access Surgery+ Suture without chlorhexidine in Post-Surgical Complication, Periodontal Inflammation and Surgical Site Infection, sponsored by Ana María García de la Fuente. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Ana María García de la Fuente · Not applicable, Interventional, and Diagnostic
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.
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.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Ana María García de la Fuente is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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 coated with chlorhexidine (Novosyn Chlorhexidine). Standardized post-surgical recommendations will be followed.
Also known as: Novosyn Clorhexidine
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
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)
Time frame: at 7 days, 14 days, 1 month and 2 months after surgery
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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The day of the removal of sutures
Plan to share: Yes — 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.
Supporting information: Statistical analysis plan
Time frame: Not defined
Access criteria: Not defined
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
Of 189 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 12 months is below that.
Counting every sponsor, half of 196 studies reached it within 24 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Ana María García de la Fuente