Pain Killer, Anxiety and Mucogingival Therapy

Sponsor

University of Liege (Other)

Overall Status

Recruiting

CT.gov ID

NCT05747092

Collaborator

(none)

Enrollment

Location

Arms

16.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety and Depression	Procedure: gingival graft	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

group test free gingival graft group control connective tissue graftgroup test free gingival graft group control connective tissue graft

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?

Actual Study Start Date :

Jan 14, 2022

Actual Primary Completion Date :

Feb 14, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group: free gingival graft for gingival recession	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
Experimental: Test group: connective tissue graft for gingival recession	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

Arm

Intervention/Treatment

Active Comparator: Control group: free gingival graft for gingival recession

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

Experimental: Test group: connective tissue graft for gingival recession

Procedure: gingival graft

Outcome Measures

Primary Outcome Measures

pin killer consumption [two weeks]
the number of pain killer used after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	leila Salhi	Liège	Liege	Belgium	4000

Sponsors and Collaborators

University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leila Salhi, PhD,Head of clinic, department of Periodontology, buccal surgery and buccal implantology,, University of Liege

ClinicalTrials.gov Identifier:

NCT05747092

Other Study ID Numbers:

B7072021000061

First Posted:

Feb 28, 2023

Last Update Posted:

Feb 28, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Feb 28, 2023