Surgical removal of lower third molars is one of the most common surgical procedures. It is associated with marked postoperative morbidity as a consequence of surgical trauma, including pain, swelling, reduced mouth opening (trismus) and a risk of wound infection and/or alveolar osteitis (dry socket). All of these sequelae have a marked impact on quality of life during the postoperative week.
Many clinical research studies have evaluated variations to surgical technique and perioperative interventions with the aim to reduce postoperative morbidity. A recent Cochrane review, updated in 2020, summarised a total of 62 trials, all of which were found to have high or unclear risk of bias and did not allow conclusions with implications for surgical practice. However, the authors acknowledge promising initial results regarding the efficacy of platelet rich plasma (PRP) or platelet rich fibrin (PRF) in reducing the incidence of alveolar osteitis following third molar surgery.
While the 2020 Cochrane review highlights promising initial results for L-PRF application in third molar surgery, the authors state that the evidence for efficacy of L-PRF to reduce postoperative morbidity is of low certainty due to quality and size of the available studies. Furthermore, the evidence was limited to alveolar osteitis (dry socket), and no conclusions could be drawn for other outcomes. No study has evaluated the effectiveness of L-PRF to improve quality of life during the recovery period.
The aim of this single-blind, randomised controlled clinical trial is therefore to evaluate the effectiveness of L-PRF applied as a wound dressing to improve quality of life during postoperative recovery and reduce postoperative pain, analgesic consumption and trismus in patients who have at least one lower third molar surgically removed.
This is a pivotal clinical trial that will use a traditional parallel group design to answer the main study question. In addition, an embedded within-person trial will also explore methodological issues on the design of clinical trials that evaluate interventions to minimise postoperative morbidity after lower third molar surgery. We have extensive experience in conducting clinical trials on third molar surgery and their methodology (see references) with a proven track record on recruitment and retention with an experienced clinical trials team to support a PhD candidate.
References:
1: Gay-Escoda C, Hanna M, Montero A, Dietrich T, Milleri S, Giergiel E, Zoltán TB, Varrassi G. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open. 2019 Feb 19;9(2):e023715. doi: 10.1136/bmjopen-2018-023715.
2: Gorecki P, Rainsford KD, Taneja P, Bulsara Y, Pearson D, Saund D, Ahmed B, Dietrich T. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial. J Dent Res. 2018 Apr;97(4):381-387. doi: 10.1177/0022034517744207. Epub 2017 Dec 4. PMID:29202646.
3: Li X, Kristunas C, Landini G, Kroeger A, Dietrich T. A novel method for the remote measurement of trismus in clinical trials using mobile phone cameras. Clin Oral Investig. 2023 Dec;27(12):7231-7236. doi: 10.1007/s00784-023-05272-z. Epub 2023 Nov 10. PMID: 37945906; PMCID: PMC10713799.
4: Li X, Niu Z, Gao C, Kroeger A, Tsakos G, Li B, Zhu J, Chen G, Dietrich T. The cross-cultural adaptation and psychometric evaluation of a Chinese version of the postoperative symptom severity (PoSSe) scale. BDJ Open. 2025 May 22;11(1):50. doi: 10.1038/s41405-025-00333-9. PMID: 40404624; PMCID:PMC12098723.
5: Gorecki P, Burke DL, Chapple ILC, Hemming K, Saund D, Pearson D, Stahl W, Lello R, Dietrich T. Perioperative supplementation with a fruit and vegetable juice powder concentrate and postsurgical morbidity: A double-blind, randomised, placebo-controlled clinical trial. Clin Nutr. 2018 Oct;37(5):1448-1455. doi:10.1016/j.clnu.2017.08.004. Epub 2017 Aug 10. PMID: 28866140.
6: Moore RA, Gay-Escoda C, Figueiredo R, Tóth-Bagi Z, Dietrich T, Milleri S, Torres-Lagares D, Hill CM, García-García A, Coulthard P, Wojtowicz A, Matenko D, Peñarrocha-Diago M, Cuadripani S, Pizà-Vallespir B, Guerrero-Bayón C, Bertolotti M, Contini MP, Scartoni S, Nizzardo A, Capriati A, Maggi CA. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541. doi: 10.1186/s10194-015-0541-5. Epub 2015 Jun 27. PMID: 26123824; PMCID: PMC4485659.
7: Dietrich T, Leeson R, Gugliotta B, Petersen B. Efficacy and safety of low dose subcutaneous diclofenac in the management of acute pain: a randomized double-blind trial. Pain Pract. 2014 Apr;14(4):315-23. doi: 10.1111/papr.12082. Epub 2013 May 22. PMID: 23692383.
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