Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548516
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Maxillary Labial Frenectomy Diode Lasers Versus Surgical Scalpel
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Patients Perceptions and Soft Tissue Changes After Conventional and Diode Laser Frenectomy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine if diode laser treatment can improve post-operative outcomes compared to conventional scalpel technique in systemically healthy non-smoking adults aged 18-45 years with aberrant papillary frenum attachment The main questions it aims to answer are
Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing
Participants will
Undergo a frenectomy procedure using either a diode laser or a conventional scalpel
Receive oral hygiene instructions and post-operative care recommendations Have their periodontal parameters measured at baseline 6 weeks and 6 months post-operation
Record their pain levels using a visual analogue scale on specified post-operative days
Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing
Participants will
Undergo a frenectomy procedure using either a diode laser or a conventional scalpel
Receive oral hygiene instructions and post-operative care recommendations Have their periodontal parameters measured at baseline 6 weeks and 6 months post-operation
Record their pain levels using a visual analogue scale on specified post-operative days
Detailed Description:
The trial will be performed as a prospective randomized and controlled single-blind investigation to study clinical parameters and patients experiences when performing a frenectomy comparing diode laser treatment with the conventional scalpel technique
Participants
This study will include 43 participants who will be identified with aberrant papillary frenum attachment according to Mirko et al and will be referred to the periodontology department The inclusion criteria for the participants will be
All participants will sign a written informed consent form before participating in the study
Study Groups and Randomization
Before any surgical procedure all subjects will undergo a thorough medical and dental history review as well as intraoral and radiographic examinations Participants who match the inclusion criteria will be provided with oral hygiene instructions tailored to their specific needs Initially the clinical periodontal parameters of all participants will be measured Then a mechanical cleaning procedure will be carried out using an ultrasonic scaler CavitronÒ Dentsply International and hand instruments Gracey 56 78 1112 1314 Hu-Friedy Ins Co A total of 43 participants will be enrolled in the study and assigned to one of two groups using a computer-based randomization table wwwgraphpadcomquickcalcs The participants will be randomly divided into two groups the experimental group which will undergo diode laser surgery L20 and the control group which will undergo conventional scalpel surgery C23
Post-treatment Procedure
After the frenectomy procedures in all groups patients will receive oral hygiene instructions and will be advised to consume soft and cold food for the next 12 hours Additionally a 012 chlorhexidine gluconate mouth rinse will be prescribed to be used once a day for one minute over five days For pain relief 500 mg of acetaminophen 1-2 tablets will be prescribed as needed with patients instructed to record the dosage and frequency of use
Clinical Evaluation
ZTE will perform all surgical procedures while a calibrated single examiner KY will perform all clinical evaluations Patients in the C group will undergo primary wound healing with sutures whereas patients in the L group will not get any sutures Therefore neither the clinicians ZTE and KY nor the patients will be kept unaware of the studys details over the entire duration In order to ensure consistency in the measurements of KY a calibration exercise was conducted until the agreement coefficient achieves a level of 90 This calibration process was consist of evaluating three patients on two separate occasions within a 24-hour period The calibration was considered effective if the variation between repeated measurements of periodontal keratinized gingival width KGW at the beginning and after 24 hours is less than 3 The clinical periodontal parameters such as the plaque index PI gingival index GI and periodontal pocket depth PD will be measured using a periodontal probe from the University of North Carolina PCPUNC15 Hu-Friedy Ins Co At baseline and at postoperative week 6 and month 6 all periodontal measurements will be taken at six sites per tooth as part of a full-mouth evaluation KGW on teeth 11 and 12 the heights of the interdental papillae between the incisors from the tip of an interdental papilla to the line joining the lowest points on the gingival margins of adjacent incisors interdental papilla width and the amount of diastema will be measured at baseline and at month 6 Before the operations the labial frenulum attachments will be classified into four types I - mucosal attachment II - gingival attachment III - papillary attachment and IV - papilla penetrating attachment Pain will be evaluated using the visual analogue scale VAS on postoperative days 1 3 7 14 21 and 28 The scale will be comprised of a horizontal line with values ranging from 0 to 10 where 0 indicates the absence of pain and 10 indicates the presence of severe discomfort
Statistical Analysis
Each patient will be accepted as one statistical unit and the statistical analysis will be performed by SPSS 20 SPSS Corporation Chicago IL with a significance level p 005 The Kolmogorov-Smirnov test will be used to check the distribution for normality Repeated measurements of clinical parameters will be analyzed with Friedman test and Wilcoxon signed-rank test The Kruskal-Wallis Chi-square and Fishers exact tests will be used to determine differences among the groups Moreover in case of significant difference among groups the Mann-Whitney U test will be used to compare two groups by Bonferroni correction
Participants
This study will include 43 participants who will be identified with aberrant papillary frenum attachment according to Mirko et al and will be referred to the periodontology department The inclusion criteria for the participants will be
All participants will sign a written informed consent form before participating in the study
Study Groups and Randomization
Before any surgical procedure all subjects will undergo a thorough medical and dental history review as well as intraoral and radiographic examinations Participants who match the inclusion criteria will be provided with oral hygiene instructions tailored to their specific needs Initially the clinical periodontal parameters of all participants will be measured Then a mechanical cleaning procedure will be carried out using an ultrasonic scaler CavitronÒ Dentsply International and hand instruments Gracey 56 78 1112 1314 Hu-Friedy Ins Co A total of 43 participants will be enrolled in the study and assigned to one of two groups using a computer-based randomization table wwwgraphpadcomquickcalcs The participants will be randomly divided into two groups the experimental group which will undergo diode laser surgery L20 and the control group which will undergo conventional scalpel surgery C23
Post-treatment Procedure
After the frenectomy procedures in all groups patients will receive oral hygiene instructions and will be advised to consume soft and cold food for the next 12 hours Additionally a 012 chlorhexidine gluconate mouth rinse will be prescribed to be used once a day for one minute over five days For pain relief 500 mg of acetaminophen 1-2 tablets will be prescribed as needed with patients instructed to record the dosage and frequency of use
Clinical Evaluation
ZTE will perform all surgical procedures while a calibrated single examiner KY will perform all clinical evaluations Patients in the C group will undergo primary wound healing with sutures whereas patients in the L group will not get any sutures Therefore neither the clinicians ZTE and KY nor the patients will be kept unaware of the studys details over the entire duration In order to ensure consistency in the measurements of KY a calibration exercise was conducted until the agreement coefficient achieves a level of 90 This calibration process was consist of evaluating three patients on two separate occasions within a 24-hour period The calibration was considered effective if the variation between repeated measurements of periodontal keratinized gingival width KGW at the beginning and after 24 hours is less than 3 The clinical periodontal parameters such as the plaque index PI gingival index GI and periodontal pocket depth PD will be measured using a periodontal probe from the University of North Carolina PCPUNC15 Hu-Friedy Ins Co At baseline and at postoperative week 6 and month 6 all periodontal measurements will be taken at six sites per tooth as part of a full-mouth evaluation KGW on teeth 11 and 12 the heights of the interdental papillae between the incisors from the tip of an interdental papilla to the line joining the lowest points on the gingival margins of adjacent incisors interdental papilla width and the amount of diastema will be measured at baseline and at month 6 Before the operations the labial frenulum attachments will be classified into four types I - mucosal attachment II - gingival attachment III - papillary attachment and IV - papilla penetrating attachment Pain will be evaluated using the visual analogue scale VAS on postoperative days 1 3 7 14 21 and 28 The scale will be comprised of a horizontal line with values ranging from 0 to 10 where 0 indicates the absence of pain and 10 indicates the presence of severe discomfort
Statistical Analysis
Each patient will be accepted as one statistical unit and the statistical analysis will be performed by SPSS 20 SPSS Corporation Chicago IL with a significance level p 005 The Kolmogorov-Smirnov test will be used to check the distribution for normality Repeated measurements of clinical parameters will be analyzed with Friedman test and Wilcoxon signed-rank test The Kruskal-Wallis Chi-square and Fishers exact tests will be used to determine differences among the groups Moreover in case of significant difference among groups the Mann-Whitney U test will be used to compare two groups by Bonferroni correction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None