Pain Management After Free Gingival Graft Surgery

Completed

• Conditions: Gingival Recession, Localized; Gingival Recession, Generalized; Gingival Recession, Mucogingival Surgery
• Interventions: Drug: diclofenac sodium solution

• Registration Number: NCT06675734
• Lead Sponsor: Istanbul Aydın University

Brief Summary

Keratinized gingiva reduces the risk of gingival disease and infection by protecting the tissue around the teeth and is therefore very important for gingival health. Free gingival grafting is a widely used technique in periodontal surgery. It is used to correct gum recession or to support the tissue around dental implants. Free gingival grafting involves taking the patient's own gum tissue from another area and transplanting it to the area in need. This method is an effective way to restore periodontal health and achieve esthetic results. Scientific studies show that free gum grafting is successful in treating gum recession and preventing complications from implant surgery. However, as with all surgical procedures, several complications can occur after free gum surgery. The most prominent of these is postoperative pain. Although various methods of pain prevention have been proposed in the literature, the most appropriate pain management strategy has not been described. The aim of this study was to evaluate the effect of analgesia methods on postoperative pain level after free gingival grafting.

Detailed Description

Human keratinized gingiva includes free and adherent gingival portions and extends from the gingival margin to the mucogingival junction. Clinical studies have concluded that a keratinized gingival margin of at least 2 mm in width is required to maintain periodontal health around teeth. Similar to periodontal health, it has been reported that insufficient keratinized gingival width in the peri-implant region can lead to problems such as plaque accumulation, pain during brushing, increased gingival inflammation, gingival recession and peri-implant bone loss. To avoid all these problems, a number of surgical procedures have been proposed to increase the width of the keratinized gingiva. Among the surgical procedures used to increase the width of the keratinized gingiva, free gingival grafting stands out for its ease of use and the fact that it requires no additional material. Free gingival grafting is an effective way to restore periodontal health and achieve esthetic results. Scientific studies show that free gingival grafting is a successful method for treating gingival recession and preventing complications in implant surgery.In free gingival grafting, the epithelial graft from the palate leaves an open wound surface that can take 2 to 4 weeks to heal. Accordingly, the most common postoperative problem is pain at the recipient and donor sites. Various surgical techniques and a number of postoperative applications have been proposed in the literature to prevent pain. These studies have mostly focused on pain control at the donor site. For example, in a study conducted with the hypothesis that an epithelial graft harvested from the donor site in a smaller size compared to traditional methods may cause less pain, it was reported that graft size had no effect on postoperative pain. On the other hand, the efficacy of different applications on the palatal wound area after free gingival transplantation using the traditional method has also been evaluated. In a systematic review, platelet-rich fibrin membrane applied to protect the donor site after surgery was shown to reduce the pain symptom. In a randomized controlled trial, a low-dose laser was also applied to the donor site, and it was reported that postoperative pain was less than in individuals without laser application. Although there are studies evaluating donor site pain control after free gingival surgery, there is no study evaluating the patient's pain control systemically. Our study was designed to contribute to the literature in this regard.

Study Timeline

• Study Start: 2023-11-29
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-27
• Status Verified: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• individuals who underwent a free gingival graft operation in which the donor site was used as the palatinal region

Exclusion Criteria

• pre-operative and post-operative complications
• The presence of any condition that prevents reading and understanding,
• Being unable to comply with the control sessions,
• Being on psychiatric medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group (Group E)	diclofenac sodium solution	After the operation, study groups will be formed according to the post operative analgesia method determined and applied by the periodontologist. Accordingly, individuals to whom diclofenac sodium-containing ampoule was administered intramuscularly within 1 hour following the operation will be included in the study group.

Primary Outcome Measures

Name	Time	Method
VAS	7 days post-operatively	Post-operative VAS Pain Scale
Medication	7 days post-operatively	Amount of post-operative pain medication use

Secondary Outcome Measures

Name	Time	Method
PROMs	3 days post-operatively	Patient-reported outcome measures questionnaire

Trial Locations

Locations (1)

Istanbul Aydin University Dentistry Faculty; 🇹🇷 Istanbul, Turkey