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Pain Killer, Anxiety and Mucogingival Therapy

U

University of Liege

Status

Enrolling

Conditions

Anxiety and Depression

Treatments

Procedure: gingival graft

Study type

Interventional

Funder types

Other

Identifiers

NCT05747092
B7072021000061

Details and patient eligibility

About

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

Full description

Anxiety and depression (HAD) scale used could be reveal the level of the patient anxiety and/or depression before intervention.

Additionnaly the use of these specific questionnaires (7 items for anxiety, 7 items for depression) could reveal if the pain killer consumption after gingical treatment is dependant to the level of HAD or to the therapy .

This tool (HAD) could allows to recognize, before any (oral)surgery, profil with high risk and propose solution to decrease anxiety and/or depression before treatment.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

Control group: free gingival graft for gingival recession
Active Comparator group
Treatment:
Procedure: gingival graft
Test group: connective tissue graft for gingival recession
Experimental group
Treatment:
Procedure: gingival graft

Trial contacts and locations

1

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Central trial contact

leila Salhi, PhD

Data sourced from clinicaltrials.gov

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