Plaque-Induced GingivitisNCT07847736
Pain Perception After Manual and Ultrasonic Periodontal Debridement in Patients With Gingivitis
A study testing Manual Supragingival Debridement and Ultrasonic Supragingival Debridement in people with Plaque-Induced Gingivitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This study compared immediate pain perception following manual and ultrasonic supragingival periodontal debridement in patients with plaque-induced gingivitis. It also evaluated whether dental anxiety, pain catastrophizing, and general pain sensitivity were associated with pain experienced during periodontal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque-Induced Gingivitis
- What is being tested?
- Manual Supragingival Debridement and Ultrasonic Supragingival Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 15 Sep 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Systemically healthy
- Diagnosed with gingivitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions
- Having an indication for non-surgical periodontal treatment
- Willing to participate in the study
Who cannot join
- Presence of any systemic disease
- Use of analgesic, antidepressant, or anxiolytic medications
- Pregnancy or breastfeeding
- Periodontal treatment within the previous 6 months
- Presence of neurological or psychiatric disorders that may affect pain perception
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Periodontology
Rize, Rize Province, 53020
About this study
Official title: EVALUATİON OF THE EFFECT OF PSYCHOLOGİCAL FACTORS ON PAİN PERCEPTİON AFTER ULTRASONİC AND MANUAL PERİODONTAL INSTRUMENTATİON: A CLİNİCAL STUDY İN PATİENTS WİTH GİNGİVİTİS
This study compared immediate pain perception following manual and ultrasonic supragingival periodontal debridement in patients with plaque-induced gingivitis. It also evaluated whether dental anxiety, pain catastrophizing, and general pain sensitivity were associated with pain experienced during periodontal instrumentation.
Participants underwent either manual supragingival debridement using hand instruments or ultrasonic supragingival debridement. Before treatment, dental anxiety, pain catastrophizing, and pain sensitivity were assessed using validated questionnaires. Immediately after the procedure, participants rated their pain intensity using a visual analog scale (VAS).
The study aimed to determine whether immediate pain perception differed between the two instrumentation methods and to examine the contribution of individual psychological and pain-related characteristics to perceived pain.
- Conditions
- Plaque-Induced Gingivitis
- Being tested
- Manual Supragingival Debridement, Ultrasonic Supragingival Debridement
- Keywords
- Periodontal Debridement, Ultrasonic Instrumentation, Manual Instrumentation, Pain Perception, Dental Anxiety, Pain Catastrophizing, Pain Sensitivity, Visual Analog Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Supragingival DebridementProcedure or surgery
Full-mouth supragingival debridement was performed using manual periodontal instruments (scalers and curettes) to remove supragingival plaque and calculus.
Ultrasonic Supragingival DebridementProcedure or surgery
Full-mouth supragingival debridement was performed using an ultrasonic periodontal device with water irrigation to remove supragingival plaque and calculus.
| Study group | Role | What they receive |
|---|---|---|
| Manual Supragingival Debridement | Active comparator | Participants underwent full-mouth supragingival debridement using manual periodontal instruments. Receives: Procedure: Manual Supragingival Debridement |
| Ultrasonic Supragingival Debridement | Active comparator | Participants underwent full-mouth supragingival debridement using an ultrasonic periodontal device. Receives: Procedure: Ultrasonic Supragingival Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Pain Intensity Assessed by Visual Analog Scale (VAS)
Immediately after supragingival debridement, participants rated the pain experienced during the procedure using a Visual Analog Scale (VAS). Higher scores indicated greater perceived pain intensity.
Measured: Immediately after completion of supragingival debridement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Aug 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque-Induced GingivitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either manual or ultrasonic supragingival debridement in an alternating sequence according to the order of enrollment.
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semih Alperen Bostan, Recep Tayyip Erdogan University
- Investigators
- SEMİH ALPEREN BOSTAN, DDS, PhD, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847736
- Sponsor's protocol ID
- 2108
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATİON OF THE EFFECT OF PSYCHOLOGİCAL FACTORS ON PAİN PERCEPTİON AFTER ULTRASONİC AND MANUAL PERİODONTAL INSTRUMENTATİON: A CLİNİCAL STUDY İN PATİENTS WİTH GİNGİVİTİS
- ClinicalTrials.gov ID
- NCT07847736
- Acronym / sponsor ID
- 2108
- Conditions
- Plaque-Induced Gingivitis
- Keywords
- Periodontal Debridement, Ultrasonic Instrumentation, Manual Instrumentation, Pain Perception, Dental Anxiety, Pain Catastrophizing, Pain Sensitivity, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 29 Sep 2026 (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.
This study compared immediate pain perception following manual and ultrasonic supragingival periodontal debridement in patients with plaque-induced gingivitis. It also evaluated whether dental anxiety, pain catastrophizing, and general pain sensitivity were associated with pain experienced during periodontal instrumentation.
Participants underwent either manual supragingival debridement using hand instruments or ultrasonic supragingival debridement. Before treatment, dental anxiety, pain catastrophizing, and pain sensitivity were assessed using validated questionnaires. Immediately after the procedure, participants rated their pain intensity using a visual analog scale (VAS).
The study aimed to determine whether immediate pain perception differed between the two instrumentation methods and to examine the contribution of individual psychological and pain-related characteristics to perceived pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to either manual or ultrasonic supragingival debridement in an alternating sequence according to the order of enrollment.
| Arm | Type | Receives |
|---|---|---|
| Manual Supragingival Debridement | Active comparator | Procedure: Manual Supragingival DebridementParticipants underwent full-mouth supragingival debridement using manual periodontal instruments. |
| Ultrasonic Supragingival Debridement | Active comparator | Procedure: Ultrasonic Supragingival DebridementParticipants underwent full-mouth supragingival debridement using an ultrasonic periodontal device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years
- Systemically healthy
- Diagnosed with gingivitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions
- Having an indication for non-surgical periodontal treatment
- Willing to participate in the study
Key exclusion criteria (5 listed)
- Presence of any systemic disease
- Use of analgesic, antidepressant, or anxiolytic medications
- Pregnancy or breastfeeding
- Periodontal treatment within the previous 6 months
- Presence of neurological or psychiatric disorders that may affect pain perception
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 |
|---|---|---|
| Manual Supragingival DebridementFull-mouth supragingival debridement was performed using manual periodontal instruments (scalers and curettes) to remove supragingival plaque and calculus. | Procedure or surgery | Manual Supragingival Debridement |
| Ultrasonic Supragingival DebridementFull-mouth supragingival debridement was performed using an ultrasonic periodontal device with water irrigation to remove supragingival plaque and calculus. | Procedure or surgery | Ultrasonic Supragingival Debridement |
Primary outcome
Immediate Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Immediately after completion of supragingival debridement
Immediately after supragingival debridement, participants rated the pain experienced during the procedure using a Visual Analog Scale (VAS). Higher scores indicated greater perceived pain intensity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection considerations.
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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.
SEMİH ALPEREN BOSTAN, DDS, PhD principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Supragingival Debridement and Ultrasonic Supragingival Debridement in people with Plaque-Induced Gingivitis, run by Recep Tayyip Erdogan 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Immediately after completion of supragingival debridement). 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 29 Sep 2026.