Pain Killer, Anxiety and Mucogingival Therapy

NCT05747092 | Unknown

• 1 other identifier: B7072021000061
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Is the pain killer consumption after gingival treatment related to the level of patient anxiety or to the type of therapy?

Conditions

Anxiety and Depression

Outcome Measures

Primary Outcomes (1)

• pin killer consumption

  the number of pain killer used after treatment

  two weeks

Study Arms (2)

Control group: free gingival graft for gingival recession

ACTIVE COMPARATOR

Procedure: gingival graft

Test group: connective tissue graft for gingival recession

EXPERIMENTAL

Procedure: gingival graft

Interventions

gingival graft PROCEDURE

investigators: Donor site: * tissue graft harvesting from the palate behind the palatal rugae . * placement of a palatine hemostatic plaque on the palate in order to reduce the risk of bleeding and to diminish the postoperative pain. Received site: * Control: the horizontal incision adjacent to the recession(s) and vertical incisions and split thickness flap. Placement of the graft on the recipient bed and suture. * Test :connective tissue graft using the " envelope/pouch " technique with two partial thickness incisions (deep and superficial). Placement of the graft inside the envelope

Control group: free gingival graft for gingival recession; Test group: connective tissue graft for gingival recession

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA type I and II subjects
• Localized Gingival Recessions
• Recessions Cairo RT I-II
• FMPS \< 10%
• FMBS\< 10%
• \<10 cigs/ day
• No contra-indication against oral surgical interventions
• Patient is able to give inform consent

You may not qualify if:

• Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to his entrance to the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
• ASA type \> II
• Current pregnancy or breastfeeding women
• Alcoholism or chronically drug abuse
• Smokers, ≳ 10 cigarettes per day
• Immunocompromised patients
• Uncontrolled diabetes
• Untreated periodontitis
• History of previous periodontal surgery (mucogingival or other) on the teeth to be included
• Presence of severe tooth malposition, rotation or significant version of the tooth to be treated

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

leila Salhi

Liège, Liege, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

leila Salhi, PhD

CONTACT

0484888091; l.salhi@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,Head of clinic, department of Periodontology, buccal surgery and buccal implantology,

Model Details: group test free gingival graft group control connective tissue graft

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 28, 2023
• Study Start: January 14, 2022
• Primary Completion: February 14, 2023
• Study Completion: June 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)