Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-Surgical Complication
- Sponsor
- Ana María García de la Fuente
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Periodontal healing index (PQI) (Landry et al., 1988)
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
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.
Investigators
Ana María García de la Fuente
Professor
University of the Basque Country (UPV/EHU)
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
Outcomes
Primary Outcomes
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
- Post-surgical complications (PSCs)(The day of the removal of sutures)
- Cytological-histological analysis(The day of the removal of sutures)
- Pain on suture removal(The day of the removal of sutures)
- Pre-surgical pain(The day of the surgical intervention)
- Post-surgical pain(At 7 days after the surgery)
- Surgery location information (location of suture, surgery time, surgeon´s experience)(The day of the surgery)
- Presence of Visible plaque on the suture(The day of the removal of sutures)
- Suture looseness(The day of the removal of sutures)
- Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)(Prior to surgery)
- Achievement of primary closure after suturing (in the surgical act).(The day of the surgery)