Pain Management After Free Gingival Graft Surgery

NCT06675734 | Completed

• 1 other identifier: 2023/148
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession, Localized; Gingival Recession, Generalized; Gingival Recession, Mucogingival Surgery

Keywords

free gingival graft; pain management; PROM; gingival augmentation

Outcome Measures

Primary Outcomes (2)

• VAS

  Post-operative VAS Pain Scale

  7 days post-operatively

• Medication

  Amount of post-operative pain medication use

  7 days post-operatively

Secondary Outcomes (1)

• PROMs

  3 days post-operatively

Study Arms (2)

Experimental Group (Group E)

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.

Drug: diclofenac sodium solution

Control Group (Group C)

Patients who do not require intramuscular administration of diclofenac sodium containing ampoule will be included in the control group.

Interventions

diclofenac sodium solution DRUG

The experimental group consisted of patients in whom diclofenac sodium was administered IM and the control group consisted of patients in whom diclofenac sodium was administered orally only.

Experimental Group (Group E)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who underwent free gingival surgery in the clinics of Istanbul Aydın University Faculty of Dentistry, Department of Periodontology.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydin University Dentistry Faculty

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession; Agnosia

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ezgi Sila Taskaldiran, PhD

  Istanbul Aydın University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IstanbulAU

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 29, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 27, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)