Pain Killer, Anxiety and Mucogingival Therapy

Anxiety and Depression Clinical Trial

Official title:

Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747092
• Other study ID #: B7072021000061
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: University of Liege
• Contact: leila Salhi, PhD
• Phone: 0484888091
• Email: l.salhi[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Depression
• Anxiety Disorders

Intervention

Procedure:
• gingival graft
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

Locations

Country	Name	City	State
Belgium	leila Salhi	Liège	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pin killer consumption	the number of pain killer used after treatment	two weeks