The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery. In order to show equivalence between Novosyn Quick and Monosyn Quick EHS, which is composed of 3 parameters: clinical signs of reepithelization, clinical signs of haemostasis and clinical signs of inflammation, will be calculated for each suture 10 ± 5 days postoperatively and cannot differ more than 2 points. Furthermore, complications, the handling of the suture material, pain, satisfaction of the patient and bacterial contamination of the thread (optional) will also be assessed as secondary objectives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
The aim of resective procedures is the re-establishment of a healthy periodontium at a reduced level, accepting as irreversible the destruction that has already occurred. In essence, these procedures are all designed to achieve pocket elimination or reduction by the apical shift of the gingival margin.
The aim of resective procedures is the re-establishment of a healthy periodontium at a reduced level, accepting as irreversible the destruction that has already occurred. In essence, these procedures are all designed to achieve pocket elimination or reduction by the apical shift of the gingival margin.
Facultat d'Odontologia. Universitat Internacional de Catalunya
Sant Cugat del Vallès, Catalonia, Spain
RECRUITINGearly wound healing score (EHS)
The primary end point in order to evaluate the primary objective of the study will be the determination of early wound healing score (EHS) in patients undergoing resective periodontal surgery. The EHS will be evaluated in 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3 or 6 points have been used to evaluate the CSR, whereas 0, 1, or 2 points have been used for both CSH and CSI (Table 3). The summation of these 3 parameters generated the EHS. The EHS for ideal wound healing was 10 points, while the worst possible score was 0 points. An EHS of 0 points was assigned in the presence of suppuration, independently of the ratings for the 3 single parameters.
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative wound dehiscence
Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Dentinal hypersensitivity
Incidence of Dentinal hypersensitivity after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Oral candidiasis
Incidence of oral candidiasis after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Angular cheilitis
Incidence of Angular cheilitis after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Swelling
Incidence of Swelling after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Bleeding
Incidence of Bleeding after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Infection
Incidence of infection after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of Systemic complications
The number of systemic complications is summarized, this includes fever, skin rash, neuropraxia, trismus, osteomyelitis, sinusitis and other complications.
Time frame: 10 ± 5 days postoperatively
Pain assessment
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain"
Time frame: 10 ± 5 days postoperatively
Satisfaction of the patient
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "not satisfied at all" and "100" at the opposite end representing "completely satisfied"
Time frame: 10 ± 5 days postoperatively
Number of patients with Bacterial contamination of the thread (optional)
Assessment of bacterial colonization on the thread of the suture will be evaluated by sending the swab of the suture to laboratory to be investigated and analysed. Polymerase Chain Reaktion Test (PCR) analysis is the test used for bacterial colonization. The micro-IDent® and micro-IDent® plus tests are able to identify 11 bacterial pathogens, including two complex pathogens.
Time frame: 10 ± 5 days postoperatively
Assessment of the handling of the suture material
Assessment of the suture material will be performed intra-operatively using a questionnaire including different dimensions (ease of passage through the tissue, first throw knot holding, knot security, knot tie down smoothness, surgical hand, memory effect and degree of fraying) with 5 point scale (excellent, very good, good, satisfied, poor) and the overall handling of the suture material.
Time frame: intraoperatively
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