PeriodontitisNCT06772506
Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis
A study testing Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) and Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint in people with Periodontitis and Stage IV Periodontitis, run by Minia University at 1 site in Egypt.
Trial summary
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Periodontitis, Stage IV Periodontitis, Minimally Invasive Treatment
- What is being tested?
- Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) and Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2022to 30 Nov 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- periodontitis stage III and IV
- Mobility grade 2
- age from 18-55 years
- medically free
- nonsmoker
- Single-rooted teeth
Who cannot join
- Medically compromised patient
- smokers
- Bad oral hygiene
- Non-surgical or surgical periodontal treatment in the past 12months.
- Prolonged treatment with antibiotics or anti-inflammatory agents within 6months before periodontal therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Patient-centered Outcomes After Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis - Randomized Controlled Clinical Trial
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.
Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.
Read more
Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.
Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?
Read the detailed description
Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, including the gingiva, periodontal ligament, cementum, and alveolar bone. The advanced stages of periodontitis, such as stage 4, are characterized by severe tissue destruction, deepened pocket depths, and alveolar bone loss, which can ultimately lead to tooth mobility, drifting, and loss. Effective therapeutic interventions are necessary to halt the progression of the disease and potentially regenerate the lost periodontal tissues.
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.
Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.
Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.
Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?
- Being tested
- Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%), Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint
- Keywords
- periodontitis, stage IV, MINST, splint
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)Procedure or surgery
non-surgical technique plus splint and ultrasonic device with 200 mg Tetracycline
Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splintProcedure or surgery
Also called with ultrasonic device, mini five and after five instruments
minimally invasive instruments, with mini five and after five minimally invasive instrument ultrasonic scaler device, conventional radiographic device and periodontal instruments with post-operative 1 gram penicillin for 3 days regulatory Statement: This study does not include an FDA-regulated device intervention, as the tools utilized are not the subject of investigation but are instead employed as part of routine clinical
| Study group | Role | What they receive |
|---|---|---|
| conventional periodontal treatment with ultrasonic device and manual instruments | Experimental | conventional non-surgical techniques with ultrasonic and manual scaler instruments Receives: Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) |
| Placebo minimally invasive non surgical technique with mini five and after five instruments | Placebo comparator | and minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation Receives: Procedure: Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAL by millimeters
Clinical attachment loss
Measured: baseline, 3months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Aug 2022
- Primary completion11 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Minia 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa hamdy, Nahda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772506
- Sponsor's protocol ID
- MINST in Periodontitis
- Other IDs
- 2019-002239-27, 2019
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: after publishing, i will share it
Publications
Hamdy S, Turky M, Gamal AY. Does minimally invasive non-surgical therapy improve outcomes in splinted mandibular incisors? Results from a randomized trial. BMC Oral Health. 2026 Jun 5;26(1):1192. doi: 10.1186/s12903-026-08788-4.
PubMed 42249403
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Patient-centered Outcomes After Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis - Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06772506
- Acronym / sponsor ID
- MINST in Periodontitis
- Keywords
- periodontitis, stage IV, MINST, splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 13 Jan 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.
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.
Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.
Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.
Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?
Detailed description
Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, including the gingiva, periodontal ligament, cementum, and alveolar bone. The advanced stages of periodontitis, such as stage 4, are characterized by severe tissue destruction, deepened pocket depths, and alveolar bone loss, which can ultimately lead to tooth mobility, drifting, and loss. Effective therapeutic interventions are necessary to halt the progression of the disease and potentially regenerate the lost periodontal tissues.
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.
Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.
Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.
Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional periodontal treatment with ultrasonic device and manual instruments | Experimental | Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)conventional non-surgical techniques with ultrasonic and manual scaler instruments |
| Placebo minimally invasive non surgical technique with mini five and after five instruments | Placebo comparator | Procedure: Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splintand minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- periodontitis stage III and IV
- Mobility grade 2
- age from 18-55 years
- medically free
- nonsmoker
Key exclusion criteria (5 listed)
- Medically compromised patient
- smokers
- Bad oral hygiene
- Non-surgical or surgical periodontal treatment in the past 12months.
- Prolonged treatment with antibiotics or anti-inflammatory agents within 6months before periodontal therapy.
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 |
|---|---|---|
| Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)non-surgical technique plus splint and ultrasonic device with 200 mg Tetracycline | Procedure or surgery | conventional periodontal treatment with ultrasonic device and manual instruments |
| Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splintAlso: with ultrasonic device, mini five and after five instrumentsminimally invasive instruments, with mini five and after five minimally invasive instrument ultrasonic scaler device, conventional radiographic device and periodontal instruments with post-operative 1 gram penicillin for 3 days regulatory Statement: This study does not include an FDA-regulated device intervention, as the tools utilized are not the subject of investigation but are instead employed as part of routine clinical | Procedure or surgery | Placebo minimally invasive non surgical technique with mini five and after five instruments |
Primary outcome
CAL by millimeters
Time frame: baseline, 3months and 6 months
Clinical attachment loss
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 14 Jan 2025.
- Derived from this study: PubMed 42249403Hamdy S, Turky M, Gamal AY. Does minimally invasive non-surgical therapy improve outcomes in splinted mandibular incisors? Results from a randomized trial. BMC Oral Health. 2026 Jun 5;26(1):1192. doi: 10.1186/s12903-026-08788-4.
- Individual participant dataSharing planned: No. after publishing, i will share it
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) and Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint in people with Periodontitis and Stage IV Periodontitis, run by Minia 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 6 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 14 Jan 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 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. Some participants in this study may receive a placebo. 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?
CAL by millimeters (time frame: baseline, 3months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06772506, which also lists 1 linked publication.
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 14 Jan 2025.