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Enrolling by Invitation

NCT Number: NCT06201377

Analysis of Early Healing of Sutures in Periodontal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Leioa, Biscay, 48940, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Novosyn Clorhexidine

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.

Other names: Novosyn

Primary outcomes

  1. Periodontal healing index (PQI) (Landry et al., 1988)

    Time frame: 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 outcomes

  1. Pre-surgical pain

    Time frame: 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.

  2. Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)

    Time frame: 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).

  3. Post-surgical pain

    Time frame: 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

  4. Achievement of primary closure after suturing (in the surgical act).

    Time frame: 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.

  5. Surgery location information (location of suture, surgery time, surgeon´s experience)

    Time frame: 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

  6. Post-surgical complications (PSCs)

    Time frame: 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.

  7. Presence of Visible plaque on the suture

    Time frame: 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.

  8. Suture looseness

    Time frame: 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.

  9. Pain on suture removal

    Time frame: 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.

  10. Cytological-histological analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ana María García de la Fuente

Other

Registry information

Official study title

Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.

Acronym: Sutures

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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