Cargando…

Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar

Background: Mesioangular impacted mandibular third molar is a common dental anomaly, for which surgical extraction is required. Post-surgery closure of mucosa reduces the prevalence of pain and other surgery-associated complications. We compared tissue reaction/inflammation after 3 and 7 days of muc...

Descripción completa

Detalles Bibliográficos
Autores principales: Balakrishna, Ramdas, Poojary, Dharnappa, R, Arvind, Sali, Shrikanth, Moharana, Ashok Kumar, TS, Deepak
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9468627/
https://www.ncbi.nlm.nih.gov/pubmed/36128557
http://dx.doi.org/10.12688/f1000research.122678.1
_version_ 1784788455262257152
author Balakrishna, Ramdas
Poojary, Dharnappa
R, Arvind
Sali, Shrikanth
Moharana, Ashok Kumar
TS, Deepak
author_facet Balakrishna, Ramdas
Poojary, Dharnappa
R, Arvind
Sali, Shrikanth
Moharana, Ashok Kumar
TS, Deepak
author_sort Balakrishna, Ramdas
collection PubMed
description Background: Mesioangular impacted mandibular third molar is a common dental anomaly, for which surgical extraction is required. Post-surgery closure of mucosa reduces the prevalence of pain and other surgery-associated complications. We compared tissue reaction/inflammation after 3 and 7 days of mucosal closure with Trusilk (®) and Mersilk (®) silk sutures, following impacted mandibular third molar removal. Methods: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (July 2020-November 2021) included subjects (Trusilk (®), n=65 and Mersilk (®), n=64), requiring mucosal suturing following impacted mandibular third molar removal. The primary endpoint, incidence of pain, swelling and trismus at the extraction area on post-surgery day 3 and 7 was evaluated. The secondary endpoints, incidence of tissue reaction, wound infection, suture loosening, other complications, operative time, amount of anesthesia, intraoperative suture handling, time needed for complete wound healing and suture removal, and adverse events were also recorded. Results: Socio-demographic and intra-oral characteristics were comparable between the groups. In Trusilk (®) and Mersilk (®) groups, a gradually decreasing pain score, starting from day 0 post-surgery (42.17±22.38 vs. 45.97±22.20) to day 7 (8.40±11.93 vs. 8.28±12.13) to day 30 (1.98±0.89 vs. 1.75±0.76) was witnessed. After the surgery, 21.54% and 17.19% subjects in Trusilk (®) and Mersilk (® )groups, respectively, had no post-operative swelling, while at the last two visits none of the subjects had swelling. Non-significant difference in wound infection, suture loosening, wound healing, bleeding, taste changes, operative time, amount of anesthesia, intraoperative suture handling, and time needed for complete wound healing and suture removal was noted among the groups. No suture-related adverse events were recorded. Conclusions: The results indicated that the Trusilk (®) and Mersilk (®) silk sutures are clinically equivalent and can be used for mucosal closure after removal of an impacted mandibular third molar with a minimal rate of pain, swelling and trismus. Clinical Trial Registry of India Registration: CTRI/2020/03/024100 (20/03/2020)
format Online
Article
Text
id pubmed-9468627
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher F1000 Research Limited
record_format MEDLINE/PubMed
spelling pubmed-94686272022-09-19 Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar Balakrishna, Ramdas Poojary, Dharnappa R, Arvind Sali, Shrikanth Moharana, Ashok Kumar TS, Deepak F1000Res Research Article Background: Mesioangular impacted mandibular third molar is a common dental anomaly, for which surgical extraction is required. Post-surgery closure of mucosa reduces the prevalence of pain and other surgery-associated complications. We compared tissue reaction/inflammation after 3 and 7 days of mucosal closure with Trusilk (®) and Mersilk (®) silk sutures, following impacted mandibular third molar removal. Methods: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (July 2020-November 2021) included subjects (Trusilk (®), n=65 and Mersilk (®), n=64), requiring mucosal suturing following impacted mandibular third molar removal. The primary endpoint, incidence of pain, swelling and trismus at the extraction area on post-surgery day 3 and 7 was evaluated. The secondary endpoints, incidence of tissue reaction, wound infection, suture loosening, other complications, operative time, amount of anesthesia, intraoperative suture handling, time needed for complete wound healing and suture removal, and adverse events were also recorded. Results: Socio-demographic and intra-oral characteristics were comparable between the groups. In Trusilk (®) and Mersilk (®) groups, a gradually decreasing pain score, starting from day 0 post-surgery (42.17±22.38 vs. 45.97±22.20) to day 7 (8.40±11.93 vs. 8.28±12.13) to day 30 (1.98±0.89 vs. 1.75±0.76) was witnessed. After the surgery, 21.54% and 17.19% subjects in Trusilk (®) and Mersilk (® )groups, respectively, had no post-operative swelling, while at the last two visits none of the subjects had swelling. Non-significant difference in wound infection, suture loosening, wound healing, bleeding, taste changes, operative time, amount of anesthesia, intraoperative suture handling, and time needed for complete wound healing and suture removal was noted among the groups. No suture-related adverse events were recorded. Conclusions: The results indicated that the Trusilk (®) and Mersilk (®) silk sutures are clinically equivalent and can be used for mucosal closure after removal of an impacted mandibular third molar with a minimal rate of pain, swelling and trismus. Clinical Trial Registry of India Registration: CTRI/2020/03/024100 (20/03/2020) F1000 Research Limited 2022-06-21 /pmc/articles/PMC9468627/ /pubmed/36128557 http://dx.doi.org/10.12688/f1000research.122678.1 Text en Copyright: © 2022 Balakrishna R et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Balakrishna, Ramdas
Poojary, Dharnappa
R, Arvind
Sali, Shrikanth
Moharana, Ashok Kumar
TS, Deepak
Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
title Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
title_full Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
title_fullStr Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
title_full_unstemmed Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
title_short Single blind, randomized study comparing clinical equivalence of Trusilk (®) and Mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
title_sort single blind, randomized study comparing clinical equivalence of trusilk (®) and mersilk (®) silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9468627/
https://www.ncbi.nlm.nih.gov/pubmed/36128557
http://dx.doi.org/10.12688/f1000research.122678.1
work_keys_str_mv AT balakrishnaramdas singleblindrandomizedstudycomparingclinicalequivalenceoftrusilkandmersilksilksuturesformucosalclosurefollowingsurgicalremovalofmesioangularimpactedmandibularthirdmolar
AT poojarydharnappa singleblindrandomizedstudycomparingclinicalequivalenceoftrusilkandmersilksilksuturesformucosalclosurefollowingsurgicalremovalofmesioangularimpactedmandibularthirdmolar
AT rarvind singleblindrandomizedstudycomparingclinicalequivalenceoftrusilkandmersilksilksuturesformucosalclosurefollowingsurgicalremovalofmesioangularimpactedmandibularthirdmolar
AT salishrikanth singleblindrandomizedstudycomparingclinicalequivalenceoftrusilkandmersilksilksuturesformucosalclosurefollowingsurgicalremovalofmesioangularimpactedmandibularthirdmolar
AT moharanaashokkumar singleblindrandomizedstudycomparingclinicalequivalenceoftrusilkandmersilksilksuturesformucosalclosurefollowingsurgicalremovalofmesioangularimpactedmandibularthirdmolar
AT tsdeepak singleblindrandomizedstudycomparingclinicalequivalenceoftrusilkandmersilksilksuturesformucosalclosurefollowingsurgicalremovalofmesioangularimpactedmandibularthirdmolar