Pain Killer, Anxiety and Mucogingival Therapy

NCT ID: NCT05747092

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Anxiety and Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

group test free gingival graft group control connective tissue graft
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group: free gingival graft for gingival recession

Group Type ACTIVE_COMPARATOR

gingival graft

Intervention Type 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

Test group: connective tissue graft for gingival recession

Group Type EXPERIMENTAL

gingival graft

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Leila Salhi

PhD,Head of clinic, department of Periodontology, buccal surgery and buccal implantology,

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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leila Salhi

Liège, Liege, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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leila Salhi, PhD

Role: CONTACT

Phone: 0484888091

Email: [email protected]

Facility Contacts

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leila Salhi, PhD

Role: primary

Other Identifiers

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B7072021000061

Identifier Type: -

Identifier Source: org_study_id