search
Back to results

Pain Killer, Anxiety and Mucogingival Therapy

Primary Purpose

Anxiety and Depression

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
gingival graft
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anxiety and Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • leila SalhiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group: free gingival graft for gingival recession

Test group: connective tissue graft for gingival recession

Arm Description

Outcomes

Primary Outcome Measures

pin killer consumption
the number of pain killer used after treatment

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
February 16, 2023
Sponsor
University of Liege
search

1. Study Identification

Unique Protocol Identification Number
NCT05747092
Brief Title
Pain Killer, Anxiety and Mucogingival Therapy
Official Title
Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Depression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
group test free gingival graft group control connective tissue graft
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group: free gingival graft for gingival recession
Arm Type
Active Comparator
Arm Title
Test group: connective tissue graft for gingival recession
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
gingival graft
Intervention Description
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
Primary Outcome Measure Information:
Title
pin killer consumption
Description
the number of pain killer used after treatment
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
leila Salhi, PhD
Phone
0484888091
Email
l.salhi@chuliege.be
Facility Information:
Facility Name
leila Salhi
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
leila Salhi, PhD
Phone
0484888091
Email
l.salhi@chuliege.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Killer, Anxiety and Mucogingival Therapy

We'll reach out to this number within 24 hrs