PeriodontitisNCT06143085
Impact of Nonsurgical Periodontal Therapy on Oral Health Related Quality of Life
A study testing Root surface debridement in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
Periodontitis is a destructive inflammatory disease of tooth supporting tissues and it adversely affects oral and general health as well as lowering the quality of life. Nonsurgical periodontal therapy is a gold standard technique for treating mild to moderate periodontitis and it was reported to significantly improve… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Root surface debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIraq
- Study dates
- 10 Oct 2022to 20 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (>18 years)
- Not reporting history of any systemic disease
- Non-smoker
- Can read and understand the questionnaire.
Who cannot join
- Patients with depression or any psychological issues
- Those not willing to participate
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry/ University of Baghdad
Baghdad
Ali A Abdulkareem, PhD, 009647806866717, ali.abbas@codental.uobaghdad.edu.iq
About this study
Official title: Impact of Nonsurgical Periodontal Therapy for Stage 2 and 3 Periodontitis on Oral Health Related Quality of Life: A Clinical Trial
Periodontitis is a destructive inflammatory disease of tooth supporting tissues and it adversely affects oral and general health as well as lowering the quality of life. Nonsurgical periodontal therapy is a gold standard technique for treating mild to moderate periodontitis and it was reported to significantly improve oral health related quality of life.
Read the detailed description
Periodontitis is a chronic disease characterized by progressive loss of tooth-supporting tissues. It is adversely affecting function, esthetic, and general wellbeing. Oral health related quality of life (OHRQoL) is the part of quality of life which is affected by oral cavity-related status. Majority of clinical studies emphasize on periodontal outcomes after periodontal therapy. However, tangible outcomes perceived by the patient such as need for re-treatment, tooth survival, and OHRQoL are mostly neglected. OHRQoL is mainly measured by using self-reported questionnaires and the most commonly used one is Oral Health Impact Profile (OHIP).
Nonsurgical periodontal therapy (NSPT) is the gold-standard technique for treating shallow to moderately deep periodontal pockets. The principle of this technique is based on mechanically disrupting subgingival dysbiotic biofilm, consequently; restoring homeostasis and healthy state of periodontal tissues. Indeed, halting progressive periodontitis is a major contributor for improving oral health and increasing tooth survival rate which are positively perceived by the patients. Previous studies consistently reporting improvement of OHRQoL following periodontal treatment. Therefore, this study aimed to investigate the impact of NSPT on OHRQoL for Stage (S)2 and S3 periodontitis patient and the factors predicting the outcomes.
- Conditions
- Periodontitis
- Being tested
- Root surface debridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root surface debridementProcedure or surgery
Periodontitis patients are treated non-surgically by supra- and subgingival debridement followed by root surface debridement for moderately deep periodontal pockets (4 to 6mm)
| Study group | Role | What they receive |
|---|---|---|
| Generalized periodontitis | Experimental | Patients diagnosed with generalized periodontitis of different severities exhibiting periodontal pockets not exceeding 6mm. Receives: Procedure: Root surface debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
The distance from the gingival margin to the base of the sulcus/pocket
Measured: PPD is assessed at baseline and 3 months after treatment
Secondary outcomes (3)
Bleeding on probing
Sign of bleeding after gentle probing of the sulcus/periodontal pocket
Measured: Baseline and 3 months after treatment
Clinical attachment level
The distance from the CEJ to the base of the sulcus/pocket
Measured: Baseline and 3 months after treatment
Oral Health Impact Profile-14
A questionnaire designed to determine oral health related quality of life consists of seven domains reflecting Functional limitation, Physical pain, Psychological discomfort, Physical disability, Psychological disability, Social disability, Handicap. Each domain composed of two questions and the scores calculation are based on a Likert scale (Never, Hardly ever, Occasionally, Often, Very often) which receive scores from 0 to 4. The higher total scores indicate worse oral health related quality of life
Measured: Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start10 Oct 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali A Abdulkareem, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143085
- Sponsor's protocol ID
- 663622
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nonsurgical Periodontal Therapy for Stage 2 and 3 Periodontitis on Oral Health Related Quality of Life: A Clinical Trial
- ClinicalTrials.gov ID
- NCT06143085
- Acronym / sponsor ID
- 663622
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 22 Nov 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.
Periodontitis is a destructive inflammatory disease of tooth supporting tissues and it adversely affects oral and general health as well as lowering the quality of life. Nonsurgical periodontal therapy is a gold standard technique for treating mild to moderate periodontitis and it was reported to significantly improve oral health related quality of life.
Detailed description
Periodontitis is a chronic disease characterized by progressive loss of tooth-supporting tissues. It is adversely affecting function, esthetic, and general wellbeing. Oral health related quality of life (OHRQoL) is the part of quality of life which is affected by oral cavity-related status. Majority of clinical studies emphasize on periodontal outcomes after periodontal therapy. However, tangible outcomes perceived by the patient such as need for re-treatment, tooth survival, and OHRQoL are mostly neglected. OHRQoL is mainly measured by using self-reported questionnaires and the most commonly used one is Oral Health Impact Profile (OHIP).
Nonsurgical periodontal therapy (NSPT) is the gold-standard technique for treating shallow to moderately deep periodontal pockets. The principle of this technique is based on mechanically disrupting subgingival dysbiotic biofilm, consequently; restoring homeostasis and healthy state of periodontal tissues. Indeed, halting progressive periodontitis is a major contributor for improving oral health and increasing tooth survival rate which are positively perceived by the patients. Previous studies consistently reporting improvement of OHRQoL following periodontal treatment. Therefore, this study aimed to investigate the impact of NSPT on OHRQoL for Stage (S)2 and S3 periodontitis patient and the factors predicting the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Generalized periodontitis | Experimental | Procedure: Root surface debridementPatients diagnosed with generalized periodontitis of different severities exhibiting periodontal pockets not exceeding 6mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>18 years)
- Not reporting history of any systemic disease
- Non-smoker
- Can read and understand the questionnaire.
Key exclusion criteria (2 listed)
- Patients with depression or any psychological issues
- Those not willing to participate
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 |
|---|---|---|
| Root surface debridementPeriodontitis patients are treated non-surgically by supra- and subgingival debridement followed by root surface debridement for moderately deep periodontal pockets (4 to 6mm) | Procedure or surgery | Generalized periodontitis |
Primary outcome
Probing pocket depth
Time frame: PPD is assessed at baseline and 3 months after treatment
The distance from the gingival margin to the base of the sulcus/pocket
3 secondary outcomes
Bleeding on probing
Time frame: Baseline and 3 months after treatment
Clinical attachment level
Time frame: Baseline and 3 months after treatment
Oral Health Impact Profile-14
Time frame: Baseline and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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 Root surface debridement in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
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 4 inclusion and 2 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 22 Nov 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 Iraq. 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 Ali A Abdulkareem, PhD (07806866717, ali.abbas@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: PPD is assessed at baseline and 3 months after 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 22 Nov 2023.