Peridontal DiseaseNCT06808373
The Effect of Hypnosis on Periodontal Treatment
A study testing hypnosis in people with Peridontal Disease and Dental Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Treatment of periodontal diseases relies on the mechanical removal of microbial dental plaque, calculus, and necrotic cementum from root surfaces in both supra- and subgingival areas to control inflammation in periodontal tissues. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Peridontal Disease, Dental Anxiety
- What is being tested?
- hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2024to 18 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 20-65 Not having any systemic disease Having chronic periodontal disease Having the ability to understand the study and answer questions
Who cannot join
- Having any systemic disease Being under 20 or over 65 Not having any periodontal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University Faculty of Dentistry
Afyonkarahisar
kübra karaçam, Assistant Professor, +90 505 939 62 58, kubrakaracam@hotmail.com
About this study
Official title: The Effect of Hypnosis on Healing in Patients Undergoing Phase I Periodontal Therapy
Treatment of periodontal diseases relies on the mechanical removal of microbial dental plaque, calculus, and necrotic cementum from root surfaces in both supra- and subgingival areas to control inflammation in periodontal tissues. As in all dental treatments, dental phobia and dental anxiety are common challenges in initial periodontal therapy. Hypnosis is among the traditional non-pharmacological behavior management techniques used to manage stress and improve pain tolerance. It is known that hypnosis is effective in anxiety control in dentistry. The use of salivary levels of inflammatory mediators released during the disease is a valid method for assessing the progression of periodontal disease and healing after treatment. In this study, the effect of hypnosis on healing in patients undergoing Phase I periodontal therapy will be evaluated by comparing the mean differences in cytokine levels between case and control groups
- Conditions
- Peridontal Disease, Dental Anxiety
- Being tested
- hypnosis
- Keywords
- periodontitis, hypnosis, dental anxiety
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
Hypnosis will be applied to periodontitis patients
| Study group | Role | What they receive |
|---|---|---|
| hypnosis | Experimental | Hypnosis will be applied to patients with periodontitis. Receives: Behavioral: hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of cytokine levels
Measured: Pre-treatment (day 0), post-treatment (day 0) and 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start18 Nov 2024
- Primary completion18 Nov 2025 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peridontal DiseaseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Karaçam, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808373
- Sponsor's protocol ID
- SBUSAH-GETAT 2024-054
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypnosis on Healing in Patients Undergoing Phase I Periodontal Therapy
- ClinicalTrials.gov ID
- NCT06808373
- Acronym / sponsor ID
- SBUSAH-GETAT 2024-054
- Conditions
- Peridontal Disease, Dental Anxiety
- Keywords
- periodontitis, hypnosis, dental anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 Nov 2025 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 5 Feb 2025 (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.
Treatment of periodontal diseases relies on the mechanical removal of microbial dental plaque, calculus, and necrotic cementum from root surfaces in both supra- and subgingival areas to control inflammation in periodontal tissues. As in all dental treatments, dental phobia and dental anxiety are common challenges in initial periodontal therapy. Hypnosis is among the traditional non-pharmacological behavior management techniques used to manage stress and improve pain tolerance. It is known that hypnosis is effective in anxiety control in dentistry. The use of salivary levels of inflammatory mediators released during the disease is a valid method for assessing the progression of periodontal disease and healing after treatment. In this study, the effect of hypnosis on healing in patients undergoing Phase I periodontal therapy will be evaluated by comparing the mean differences in cytokine levels between case and control groups
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypnosis | Experimental | Behavioral: hypnosisHypnosis will be applied to patients with periodontitis. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being between the ages of 20-65 Not having any systemic disease Having chronic periodontal disease Having the ability to understand the study and answer questions
Key exclusion criteria (1 listed)
- Having any systemic disease Being under 20 or over 65 Not having any periodontal disease
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 |
|---|---|---|
| hypnosisHypnosis will be applied to periodontitis patients | Behavioural | hypnosis |
Primary outcome
measurement of cytokine levels
Time frame: Pre-treatment (day 0), post-treatment (day 0) and 8 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis in people with Peridontal Disease and Dental Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Feb 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra Karaçam Karaçam, Assistant Professor (+90 505 939 62 58, kubrakaracam@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of cytokine levels (time frame: Pre-treatment (day 0), post-treatment (day 0) and 8 weeks post-treatment). 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 5 Feb 2025.