Anxiety and DepressionNCT05747092
Pain Killer, Anxiety and Mucogingival Therapy
A study testing gingival graft in people with Anxiety and Depression, run by University of Liege at 1 site in Belgium.
Trial summary
Is the pain killer consumption after gingival treatment related to the level of patient anxiety or to the type of therapy? Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Depression
- What is being tested?
- gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
leila Salhi
Liège, Liege, 4000
leila Salhi, PhD, 0484888091, l.salhi@chuliege.be
About this study
Official title: Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?
Is the pain killer consumption after gingival treatment related to the level of patient anxiety or to the type of therapy?
Read the 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.
- Conditions
- Anxiety and Depression
- Being tested
- gingival graft
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival graftProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control group: free gingival graft for gingival recession | Active comparator | Not described Receives: Procedure: gingival graft |
| Test group: connective tissue graft for gingival recession | Experimental | Not described Receives: Procedure: gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
pin killer consumption
the number of pain killer used after treatment
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start14 Jan 2022
- Primary completion14 Feb 2023
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- group test free gingival graft group control connective tissue graft
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Salhi, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747092
- Sponsor's protocol ID
- B7072021000061
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?
- ClinicalTrials.gov ID
- NCT05747092
- Acronym / sponsor ID
- B7072021000061
- Conditions
- Anxiety and Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- group test free gingival graft group control connective tissue graft
| Arm | Type | Receives |
|---|---|---|
| Control group: free gingival graft for gingival recession | Active comparator | Procedure: gingival graft |
| Test group: connective tissue graft for gingival recession | Experimental | Procedure: gingival graft |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ASA type I and II subjects
- Localized Gingival Recessions
- Recessions Cairo RT I-II
- FMPS < 10%
- FMBS< 10%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingival graftinvestigators: 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 | Procedure or surgery | Control group: free gingival graft for gingival recession, Test group: connective tissue graft for gingival recession |
Primary outcome
pin killer consumption
Time frame: two weeks
the number of pain killer used after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gingival graft in people with Anxiety and Depression, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact leila Salhi, PhD (0484888091, l.salhi@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pin killer consumption (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.