Periodontal DiseaseEarly Phase 1NCT07671274
Comparison of the Efficacy of Conventional Versus Minimally Invasive Non-Surgical Periodontal Therapy in Periodontitis Patients
A Early Phase 1 study testing Mechanical debridement . and minimally invasive mechanical debridement in people with Periodontal Disease and Stage III Periodontitis, run by Mansoura University at 1 site in Egypt.
Trial summary
the aim of this study is to investigate the clinical outcomes of Minimally Invasive Non-Surgical Therapy(MINST) compared to Conventional non-surgical periodontal therapy (CNST) Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Stage III Periodontitis
- What is being tested?
- Mechanical debridement . and minimally invasive mechanical debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to 5 Aug 2026
- Phase
- Early Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients with stage III pericdontitis, according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification system .
- Medically free patients.
- Non-smokers
- Patients with good oral hygiene.
Who cannot join
- Pregnant or lactating females.
- Patients with systemic diseases that might affect periodontal health
- previous periodontal treatment within 6 months before baseline examination.
- prior antibiotic regimen use within 1 month before baseline examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university Faculty of dentistry
Al Mansurah, Dakhlia, 00000
fatma saad elsherbini, phd, +201128065677, elsherbinifatma@mans.edu.eg
About this study
Official title: Comparison of the Efficacy of Conventional Versus Minimally Invasive Non-Surgical Periodontal Therapy in Periodontitis Patients (Randomized Controlled Clinical Trial)
the aim of this study is to investigate the clinical outcomes of Minimally Invasive Non-Surgical Therapy(MINST) compared to Conventional non-surgical periodontal therapy (CNST)
Read the detailed description
A total of thirty patients were included in the study, Inclusion Criteria: -
- Patients with stage III pericdontitis, according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification system .
- Medically free patients.
- Non-smokers
- Patients with good oral hygiene. Exclusion Criteria: -
- Pregnant or lactating females.
- Patients with systemic diseases that might affect periodontal health
- previous periodontal treatment within 6 months before baseline examination.
- prior antibiotic regimen use within 1 month before baseline examination All participants will receive oral hygiene instructions including toothbrushin, interdental cleaning, and plaque control behavior reinforcement with oral hygiene self-care regimens to be followed at home.
- On the conventional non-surgical periodontal therapy side, a power-driven piezo•electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus. and manual standard gracey curette instruments will be used to refine residuals from root surfaces.
- Conversely, the treatment protocol of the minimally invasive non-surgical periodontal therapy side will be followed as in the previous study (5).
- Briefly. the root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed.
- Both modalities will be performed under local anesthesia.
- All patients will be recalled 1 and 3 months after tre.alment for re-ev.almtion and professional supra-gingival plaque control study parameters are plaque index bleeding of probing periodontal pocket depth clinical attachment loss gingival index
- Conditions
- Periodontal Disease, Stage III Periodontitis
- Being tested
- Mechanical debridement ., minimally invasive mechanical debridement
- Keywords
- periodontitis, stage III, mechanical debridement
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridement .Device
On the conventional non-surgical periodontal therapy side, a power-driven piezo•electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus. and manual standard gracey curette instruments will be used to refine residuals from root surfaces.
minimally invasive mechanical debridementDevice
Briefly. the root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed.
| Study group | Role | What they receive |
|---|---|---|
| conventional non-surgical periodontal therapy | Experimental | conventional mechanical debridement Receives: Device: Mechanical debridement . |
| Minimally Invasive Non-Surgical Therapy | Experimental | the root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed. Receives: Device: minimally invasive mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (PI)
- Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present.
0: No plaque is visible.
- A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe.
- Visible plaque along the gingival margin.
- Heavy plaque accumulation in the gingival margin and interdental spaces.
Measured: basline, 1 month , 3 months
Bleeding on probing (BOP):
): "0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.
Measured: baseline, 1 month , 3 months
Probing pocket Depth (PPD)
): will be measured from the gingival margin to the base of the periodontal pocket.
Measured: baseline , 1 month , 3 month
Clinical Attachment Level (CAL)
will be measured from the cement-enamel junction to the base of the periodontal pocket.
Measured: baseline ,1 month , 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start5 Aug 2025
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma saad saad mahmoud elsherbini, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671274
- Sponsor's protocol ID
- R.25.07.9 - 2025/08/05
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Conventional Versus Minimally Invasive Non-Surgical Periodontal Therapy in Periodontitis Patients (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07671274
- Acronym / sponsor ID
- R.25.07.9 - 2025/08/05
- Conditions
- Periodontal Disease, Stage III Periodontitis
- Keywords
- periodontitis, stage III, mechanical debridement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 26 Jun 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.
the aim of this study is to investigate the clinical outcomes of Minimally Invasive Non-Surgical Therapy(MINST) compared to Conventional non-surgical periodontal therapy (CNST)
Detailed description
A total of thirty patients were included in the study, Inclusion Criteria: -
- Patients with stage III pericdontitis, according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification system .
- Medically free patients.
- Non-smokers
- Patients with good oral hygiene. Exclusion Criteria: -
- Pregnant or lactating females.
- Patients with systemic diseases that might affect periodontal health
- previous periodontal treatment within 6 months before baseline examination.
- prior antibiotic regimen use within 1 month before baseline examination All participants will receive oral hygiene instructions including toothbrushin, interdental cleaning, and plaque control behavior reinforcement with oral hygiene self-care regimens to be followed at home.
- On the conventional non-surgical periodontal therapy side, a power-driven piezo•electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus. and manual standard gracey curette instruments will be used to refine residuals from root surfaces.
- Conversely, the treatment protocol of the minimally invasive non-surgical periodontal therapy side will be followed as in the previous study (5).
- Briefly. the root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed.
- Both modalities will be performed under local anesthesia.
- All patients will be recalled 1 and 3 months after tre.alment for re-ev.almtion and professional supra-gingival plaque control study parameters are plaque index bleeding of probing periodontal pocket depth clinical attachment loss gingival index
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional non-surgical periodontal therapy | Experimental | Device: Mechanical debridement .conventional mechanical debridement |
| Minimally Invasive Non-Surgical Therapy | Experimental | Device: minimally invasive mechanical debridementthe root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Patients with stage III pericdontitis, according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification system .
Key exclusion criteria (4 listed)
- Pregnant or lactating females.
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 |
|---|---|---|
| Mechanical debridement .On the conventional non-surgical periodontal therapy side, a power-driven piezo•electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus. and manual standard gracey curette instruments will be used to refine residuals from root surfaces. | Device | conventional non-surgical periodontal therapy |
| minimally invasive mechanical debridementBriefly. the root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed. | Device | Minimally Invasive Non-Surgical Therapy |
Primary outcome
Plaque index (PI)
Time frame: basline, 1 month , 3 months
1. Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present. 0: No plaque is visible. 1. A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe. 2. Visible plaque along the gingival margin. 3. Heavy plaque accumulation in the gingival margin and interdental spaces.
Bleeding on probing (BOP):
Time frame: baseline, 1 month , 3 months
): "0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.
Probing pocket Depth (PPD)
Time frame: baseline , 1 month , 3 month
): will be measured from the gingival margin to the base of the periodontal pocket.
Clinical Attachment Level (CAL)
Time frame: baseline ,1 month , 3 month
will be measured from the cement-enamel junction to the base of the periodontal pocket.
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 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Mechanical debridement . and minimally invasive mechanical debridement in people with Periodontal Disease and Stage III Periodontitis, run by Mansoura University at 1 site in Egypt.
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 4 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 26 Jun 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 fatma saad elsherbini, phd (+201128065677, elsherbinifatma@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (PI) (time frame: basline, 1 month , 3 months). The study lists 4 primary outcomes in all. 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 26 Jun 2026.