Periodontal DiseasesNCT06578403
Effect of Internal and External Micro-needling in Treatment of Stage III Periodontitis
A study testing external microneedling, minimally invasive non- surgical periodontal therapy and internal micro_needling in people with Periodontal Diseases, run by Misr University for Science and Technology.
Trial summary
Periodontitis is a dysbiotic disease characterized by the destruction of the periodontium (alveolar bone, cementum, periodontal ligament, gingiva) and considered the main cause of tooth loss which is linked to a change in the microbial community from primarily beneficial bacteria, known as 'symbionts', to an imbalance… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- external microneedling, minimally invasive non- surgical periodontal therapy and internal micro_needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 Sep 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female systematic health
- age ≥ 18 years
- Provide informed consent and willingness to cooperate with the study protocol.
- Periodontitis stage III patients:
- Probing depth≥6 mm
- CAL ≥5 mm.
Show all 9Show fewer
- Radiographic bone loss (Extending to middle and beyond)
- Tooth loss ≥4 teeth.
- Each patient contributed a maximum of two sides.
Who cannot join
- smoker
- History of antibiotic in previous three months.
- Pregnant or lactating.
- Treatment with any systemic drug that influences the healing of hard and soft tissues.
- Patients who received periodontal treatment in the last 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Minimally Invasive Non-surgical Therapy Augmented With Internal Versus External Micro-needling in Treatment of Stage Iii Periodontitis: a Randomized Controlled Clinical Trial and Biochemical Trial
Periodontitis is a dysbiotic disease characterized by the destruction of the periodontium (alveolar bone, cementum, periodontal ligament, gingiva) and considered the main cause of tooth loss which is linked to a change in the microbial community from primarily beneficial bacteria, known as 'symbionts', to an imbalance with a high presence of harmful bacteria 'dysbiosis', also known as 'pathobionts'.
Ideally, periodontal therapy should eliminate inflammation, arrest the advancement of periodontal disease, enhance appearance, and create an environment conducive to health maintenance.Microneedling (MN) is known as "percutaneous collagen induction therapy." Micro injuries created by MN result in minimal superficial bleedings and create a wound-healing The body responds to micro-needling as if it's experiencing tissue trauma, leading to the release of various growth factors such as platelet-derived growth factors, transforming growth factors, connective tissue growth factors, and fibroblast growth factors. These growth factors induce the production of collagen to preserve skin integrity. After an injury, growth factors are released, promoting the proliferation of new cells. From day 5 to week 8, fibroblasts produce collagen and elastin fibers, thickening the tissue in a process known as neocollagenesis. Additionally, fibroblasts trigger neoangiogenesis by stimulating the proliferation of endothelial cells in the vessels. According to a randomized clinical trial comparing micro-needling and acellular dermal matrix, significant improvements were observed in various parameters(GT, RW, RD, CAL, PD, Rec- Red, and percentage of root coverage, with reduced PI and BOP at 3 and 6 months this study aim to The effect of minimally invasive non-surgical augmented with micro-needling, both externally and internally, for the management of stage III periodontitis
Read the detailed description
Study Settings and Source of Patients The study will take place in the outpatient clinics of the oral medicine, periodontology, and Diagnosis department at the Faculty of Oral and Dental Surgery at Misr University for Science and Technology. All procedures will be conducted with the approval of the Research Ethics Committee (REC) of the Faculty of Oral and Dental Surgery at Misr University for Science and Technology.
SIX periodontitis stage III patients seeking periodontal therapy will be included in this study. The selection of patients will be done after careful clinical, radiographic, and periodontal examination according to the following inclusion and exclusion criteria.
Methods of measurement of outcome:
Clinical Parameters:
The following parameters will be recorded at baseline, 3 months after initial periodontal therapy and after 6 months.
- Probing depth: UNC 15 probe will be used to measure the pocket depth from the gingival margin to the base of the pocket.
- Gingival index [GI]: It is used to assess gingival inflammation .
- Clinical attachment level [CAL]): Represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction (CEJ) to the base of the pocket .
- plaque index: The desirability of distinguishing clearly between the soft debris aggregates' severity and location.
- Bleeding on probing POB: bleeding indices have been devised; some assess bleeding as simply present or absent, whereas others use grading in an attempt to assess severity of bleeding
- Vas index :
A Visual Analogue Scale (VAS) is a pain rating scale 1,2,3,4,5,6,7,8,9 Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
Biological assessment(Platelet-derived growth factor(PDGF) levels in gingival crevicular fluid Assessment of PDGF in gingival crevicular fluid at baseline,7,14 days
- Conditions
- Periodontal Diseases
- Being tested
- external microneedling, minimally invasive non- surgical periodontal therapy, internal micro_needling
- Keywords
- microneedling, periodontitis, Minimally invasive non-surgical therapy
- 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.
external microneedlingDevice
external micro_needling
minimally invasive non- surgical periodontal therapyOther
minimally invasive non- surgical periodontal therapy
internal micro_needlingDevice
internal micro_ needling
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | minimally invasive non-surgical technique (MINST) in management of periodontitis stage III patients. Receives: Other: minimally invasive non- surgical periodontal therapy |
| external intervention | Experimental | minimally invasive non-surgical technique (MINST) with external microneedle (EMN) periodontitis stage III patients. Receives: Device: external microneedling; Other: minimally invasive non- surgical periodontal therapy |
| internal intervention | Experimental | minimally invasive non-surgical technique with an internal microneedle (IMN) on periodontitis stage III patients. Receives: Other: minimally invasive non- surgical periodontal therapy; Device: internal micro_needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
measure the pocket depth from the gingival margin to the base of the pocket using UNC 15 probe (mm)
Measured: 6month
Clinical attachment level [CAL]):
measured with the periodontal probe as the distance from the cemento-enamel junction(CEJ) to the base of the pocket by UNC 15 probe (mm)
Measured: 6month
plaque index
The desirability of distinguishing clearly between the soft debris aggregates' severity and location by system Score 0 = The tooth surface is clean. - Score 1 = The tooth surface appears clean, but dental plaque can be removed from the gingival third with a sharp explorer. - Score 2 = Plaque is visible along the gingival margin. - Score 3 = The tooth surface is covered with abundant plaque
Measured: 6 month
Bleeding on probing
bleeding indices have been devised; some assess bleeding as simply present or absent, whereas others use grading in an attempt to assess severity of bleeding is the score criteria: 0: no bleeding 1: one bleeding point appears 2: multiple bleeding points or one bleeding line appear 3: interdental triangle filled with blood 4: excessive bleeding when probing and blood flow to the marginal sulcus
Measured: 6 month
Secondary outcomes (3)
A Visual Analogue Scale (VAS)
a pain rating scale 1,2,3,4,5,6,7,8,9 Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
Measured: immediately after phase 1 therapy
Platelet-derived growth factor (PDGF) levels in gingival crevicular fluid
PDGF are major mitogens for many cell types of mesenchymal origin and for some cells that are neuroectodermal in origin, like oligodendrocytes. PDGF have chemoattractant properties and have been involved in bone formation, erythropoiesis, wound healing and angiogenesis
Measured: baseline,7,14 days.
crestal bone level
assessment of crestal bone level by periapical x-ray
Measured: after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Nassar abdelhamied ali, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578403
- Sponsor's protocol ID
- MisrUST. MICRONEEDLE
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Non-surgical Therapy Augmented With Internal Versus External Micro-needling in Treatment of Stage Iii Periodontitis: a Randomized Controlled Clinical Trial and Biochemical Trial
- ClinicalTrials.gov ID
- NCT06578403
- Acronym / sponsor ID
- MisrUST. MICRONEEDLE
- Conditions
- Periodontal Diseases
- Keywords
- microneedling, periodontitis, Minimally invasive non-surgical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Aug 2024 (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 dysbiotic disease characterized by the destruction of the periodontium (alveolar bone, cementum, periodontal ligament, gingiva) and considered the main cause of tooth loss which is linked to a change in the microbial community from primarily beneficial bacteria, known as 'symbionts', to an imbalance with a high presence of harmful bacteria 'dysbiosis', also known as 'pathobionts'.
Ideally, periodontal therapy should eliminate inflammation, arrest the advancement of periodontal disease, enhance appearance, and create an environment conducive to health maintenance.Microneedling (MN) is known as "percutaneous collagen induction therapy." Micro injuries created by MN result in minimal superficial bleedings and create a wound-healing The body responds to micro-needling as if it's experiencing tissue trauma, leading to the release of various growth factors such as platelet-derived growth factors, transforming growth factors, connective tissue growth factors, and fibroblast growth factors. These growth factors induce the production of collagen to preserve skin integrity. After an injury, growth factors are released, promoting the proliferation of new cells. From day 5 to week 8, fibroblasts produce collagen and elastin fibers, thickening the tissue in a process known as neocollagenesis. Additionally, fibroblasts trigger neoangiogenesis by stimulating the proliferation of endothelial cells in the vessels. According to a randomized clinical trial comparing micro-needling and acellular dermal matrix, significant improvements were observed in various parameters(GT, RW, RD, CAL, PD, Rec- Red, and percentage of root coverage, with reduced PI and BOP at 3 and 6 months this study aim to The effect of minimally invasive non-surgical augmented with micro-needling, both externally and internally, for the management of stage III periodontitis
Detailed description
Study Settings and Source of Patients The study will take place in the outpatient clinics of the oral medicine, periodontology, and Diagnosis department at the Faculty of Oral and Dental Surgery at Misr University for Science and Technology. All procedures will be conducted with the approval of the Research Ethics Committee (REC) of the Faculty of Oral and Dental Surgery at Misr University for Science and Technology.
SIX periodontitis stage III patients seeking periodontal therapy will be included in this study. The selection of patients will be done after careful clinical, radiographic, and periodontal examination according to the following inclusion and exclusion criteria.
Methods of measurement of outcome:
Clinical Parameters:
The following parameters will be recorded at baseline, 3 months after initial periodontal therapy and after 6 months.
- Probing depth: UNC 15 probe will be used to measure the pocket depth from the gingival margin to the base of the pocket.
- Gingival index [GI]: It is used to assess gingival inflammation .
- Clinical attachment level [CAL]): Represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction (CEJ) to the base of the pocket .
- plaque index: The desirability of distinguishing clearly between the soft debris aggregates' severity and location.
- Bleeding on probing POB: bleeding indices have been devised; some assess bleeding as simply present or absent, whereas others use grading in an attempt to assess severity of bleeding
- Vas index :
A Visual Analogue Scale (VAS) is a pain rating scale 1,2,3,4,5,6,7,8,9 Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
Biological assessment(Platelet-derived growth factor(PDGF) levels in gingival crevicular fluid Assessment of PDGF in gingival crevicular fluid at baseline,7,14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 1:1:1
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: minimally invasive non- surgical periodontal therapyminimally invasive non-surgical technique (MINST) in management of periodontitis stage III patients. |
| external intervention | Experimental | Device: external microneedling, Other: minimally invasive non- surgical periodontal therapyminimally invasive non-surgical technique (MINST) with external microneedle (EMN) periodontitis stage III patients. |
| internal intervention | Experimental | Other: minimally invasive non- surgical periodontal therapy, Device: internal micro_needlingminimally invasive non-surgical technique with an internal microneedle (IMN) on periodontitis stage III patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or Female systematic health
- age ≥ 18 years
- Provide informed consent and willingness to cooperate with the study protocol.
- Periodontitis stage III patients:
- Probing depth≥6 mm
Key exclusion criteria (5 listed)
- smoker
- History of antibiotic in previous three months.
- Pregnant or lactating.
- Treatment with any systemic drug that influences the healing of hard and soft tissues.
- Patients who received periodontal treatment in the last 6 months
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 |
|---|---|---|
| external microneedlingexternal micro_needling | Device | external intervention |
| minimally invasive non- surgical periodontal therapyminimally invasive non- surgical periodontal therapy | Other | control, external intervention, internal intervention |
| internal micro_needlinginternal micro_ needling | Device | internal intervention |
Primary outcome
Probing depth
Time frame: 6month
measure the pocket depth from the gingival margin to the base of the pocket using UNC 15 probe (mm)
Clinical attachment level [CAL]):
Time frame: 6month
measured with the periodontal probe as the distance from the cemento-enamel junction(CEJ) to the base of the pocket by UNC 15 probe (mm)
plaque index
Time frame: 6 month
The desirability of distinguishing clearly between the soft debris aggregates' severity and location by system Score 0 = The tooth surface is clean. - Score 1 = The tooth surface appears clean, but dental plaque can be removed from the gingival third with a sharp explorer. - Score 2 = Plaque is visible along the gingival margin. - Score 3 = The tooth surface is covered with abundant plaque
Bleeding on probing
Time frame: 6 month
bleeding indices have been devised; some assess bleeding as simply present or absent, whereas others use grading in an attempt to assess severity of bleeding is the score criteria: 0: no bleeding 1: one bleeding point appears 2: multiple bleeding points or one bleeding line appear 3: interdental triangle filled with blood 4: excessive bleeding when probing and blood flow to the marginal sulcus
3 secondary outcomes
A Visual Analogue Scale (VAS)
Time frame: immediately after phase 1 therapy
Platelet-derived growth factor (PDGF) levels in gingival crevicular fluid
Time frame: baseline,7,14 days.
crestal bone level
Time frame: after 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing external microneedling, minimally invasive non- surgical periodontal therapy and internal micro_needling in people with Periodontal Diseases, run by Misr University for Science and Technology.
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 9 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 hasnaa nassar, B.D.S (01060949487, hasnaa.nassar@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 6month). 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 29 Aug 2024.