Periodontitis, AdultNCT04149834
Clinical and Radiographic Evaluation of NIPSA Versus M-MIST in Treatment of Intra-osseous Defects
A study testing Group A (Test): Patients will receive NIPSA in people with Periodontitis, Adult, run by Cairo University at 1 site in Egypt.
Trial summary
The aim: Clinical and Radiographic Evaluation for intra-osseous defects in stage III periodontitis using NIPSA versus M-MIST Steps in short Pre-surgical therapy Before surgical intervention, each patient will be given careful instructions on proper oral hygiene measures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Group A (Test): Patients will receive NIPSA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Oct 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stage III periodontitis patient having at least one tooth with Two walls or combined 2- to 3-walls intraosseous defects ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- Defect not extended to a root furcation area.
- Vital teeth
- Non-smokers.
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- No periodontal therapy carried out in the past 6 months.
Show all 11Show fewer
- Able to sign an informed consent form.
- Patients age between 20 and 60 years old.
- Patients who are cooperative, motivated, and hygiene conscious.
- Able to come for the follow up appointment's needed.
- Systemically free according to Modified Cornell Medical Index health questionnaire (Kark et al., 1964).
Who cannot join
- Pregnancy or breast feeding.
- The presence of an orthodontic appliance.
- Teeth mobility greater than grade I.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unv
Cairo, 02
Cairo Unv, 0223634965, Perio@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of Non-Incised Papilla Surgical Approach Versus Modified Minimally Invasive Surgical Technique in Treatment of Intra-osseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
The aim: Clinical and Radiographic Evaluation for intra-osseous defects in stage III periodontitis using NIPSA versus M-MIST Steps in short Pre-surgical therapy
- Before surgical intervention, each patient will be given careful instructions on proper oral hygiene measures.
Read more
Surgical Procedures:
- Group B (Control): Patients will receive Modified Minimally Invasive Surgical technique (M-MIST) Group A (Test): Patients will receive Non-Incised Papilla Surgical Approach (NIPSA) Postoperative medication
- Administration of amoxicillin (500 mg tabs) T.I.D for 7 days and Metronidazole (500 mg tabs) T.I.D for 7 days
- Rinsing with Chlorhexidine 0.12% (B.I.D for 14 days).
- Ibuprofen 600 mg tabs once every 8h could be administrated in case of unbearable pain
- Follow up period: after 8 weeks/ after surgery by 1 week- 1 month- 3 months- 6 months- 1 year
Read the detailed description
P: Population: Stage III periodontitis presenting intraosseous defects I: Intervention: Non-Incised Papilla Surgical Approach (NIPSA) C: Control: Modified Minimally Invasive Surgical Technique (M-MIST) O: Outcome measurements T: 1- year S: Randomized clinical trial
Surgical Procedures:
The operator will anesthetize the surgical sites with 4% ARTINIBSA containing Articaine hydrochloride Epinephrine (adrenaline) 1: 100.000 injection for both groups. For patients that recieved (NIPSA) as reported by (Moreno Rodríguez and Caffesse 2017).
- After locally anesthetizing the area an apical horizontal incision on the buccal mucosa, as far as possible from the interdental papillae and marginal KT will be performed. Soft tissue will be reflected apico-coronally by a full-thickness flap showing the granulation tissue filling the bony defect after exposing the coronal limit of the intra-bony component of the defect, while the marginal tissue will be kept unaltered.
- Horizontal mattress sutures with single interrupted sutures will be placed as the second line of closure. while patients that received (M-MIST) reported by (Banthia et al. 2016a)
- Access to the defect will be gained through the tiny buccal triangular flap: from the buccal 'window' the soft tissue filling the defect (i.e. the so-called granulation tissue) will be sharply dissected from the papillary supra-crestal connective tissue and from the bony walls with a micro-blade and will be removed with a mini-curette (The soft tissue will be sharply dissected from the osseous defect)
- No interdental and/or lingual intra-sulcular incisions will be performed. The supra-crestal interdental tissues.
- Surgical flaps will be sutured to the pre-surgical level with 5-0 vicryl suture utilizing single interrupted suturing techniques that will achieve primary closure.
- Sutures will be removed 2 weeks post-surgically. Patients will be asked to discontinue mechanical tooth-brushing technique in the surgical area for 2 weeks.
- After this period, patients will be instructed to continue mechanical tooth brushing again of the treated sites using a soft toothbrush.
Patients will be recalled monthly for supportive periodontal therapy during the course of the study. And then will be recalled every six months for supportive periodontal therapy after the study.
- Conditions
- Periodontitis, Adult
- Being tested
- Group A (Test): Patients will receive NIPSA, Group B (Control): Patients will receive M-MIST
- Keywords
- Intraossous defects, Periodontitis
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Test): Patients will receive NIPSAProcedure or surgery
patients received Non- incised papilla surgical approache
Group B (Control): Patients will receive M-MISTProcedure or surgery
patients received Modified Minimally Invasive Surgical Technique
| Study group | Role | What they receive |
|---|---|---|
| Modified Minimally Invasive Surgical Technique | Active comparator | Comparator: Modified Minimally Invasive Surgical Technique The defect will be gained through the tiny buccal triangular flap: from the buccal 'window' the soft tissue filling the defect (i.e. the so-called granulation tissue) will be sharply dissected from the papillary supra-crestal connective tissue and from the bony walls with a micro-blade and will be removed with a mini-curette (The soft tissue will be sharply dissected from the osseous defect) Receives: Procedure: Group B (Control): Patients will receive M-MIST |
| Non- incised papilla surgical approach | Other | intervention: Non- incised papilla surgical approach Apical horizontal incision on the buccal mucosa, as far as possible from the interdental papillae and marginal KT will be performed. Soft tissue will be reflected apico-coronally by a full-thickness flap showing the granulation tissue filling the bony defect after exposing the coronal limit of the intra-bony component of the defect, while the marginal tissue will be kept unaltered. Receives: Procedure: Group A (Test): Patients will receive NIPSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of CAL gain
Clinical attachment Level gain (CAL) by UNC Periodontal probe (mm)
Measured: baseline/ after 6 months & 1 year post-surgical
Secondary outcomes (3)
Assessment of PD reduction
UNC Perioodntal probe (mm)
Measured: 1 year
gingival recession
UNC Perioodntal probe (mm)
Measured: 1 year
radiographic bone fill.
Linear measurements standardized periapical radiograph (mm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 May 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- • The patients will be randomly assigned into two groups: Group A (Test): Patients will receive Non-Incised Papilla Surgical Approach (NIPSA) • Group B (Control): Patients will receive Modified Minimally Invasive Surgical technique (M-MIST)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa EL-Desouky Helal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149834
- Sponsor's protocol ID
- PER3-3-2
- Status last verified
- Oct 2019
- First submitted
- 20 Oct 2019
- Last updated
- 4 Nov 2019
- 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 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Non-Incised Papilla Surgical Approach Versus Modified Minimally Invasive Surgical Technique in Treatment of Intra-osseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04149834
- Acronym / sponsor ID
- PER3-3-2
- Conditions
- Periodontitis, Adult
- Keywords
- Intraossous defects, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 4 Nov 2019 (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: Clinical and Radiographic Evaluation for intra-osseous defects in stage III periodontitis using NIPSA versus M-MIST Steps in short Pre-surgical therapy
- Before surgical intervention, each patient will be given careful instructions on proper oral hygiene measures.
Surgical Procedures:
- Group B (Control): Patients will receive Modified Minimally Invasive Surgical technique (M-MIST) Group A (Test): Patients will receive Non-Incised Papilla Surgical Approach (NIPSA) Postoperative medication
- Administration of amoxicillin (500 mg tabs) T.I.D for 7 days and Metronidazole (500 mg tabs) T.I.D for 7 days
- Rinsing with Chlorhexidine 0.12% (B.I.D for 14 days).
- Ibuprofen 600 mg tabs once every 8h could be administrated in case of unbearable pain
- Follow up period: after 8 weeks/ after surgery by 1 week- 1 month- 3 months- 6 months- 1 year
Detailed description
P: Population: Stage III periodontitis presenting intraosseous defects I: Intervention: Non-Incised Papilla Surgical Approach (NIPSA) C: Control: Modified Minimally Invasive Surgical Technique (M-MIST) O: Outcome measurements T: 1- year S: Randomized clinical trial
Surgical Procedures:
The operator will anesthetize the surgical sites with 4% ARTINIBSA containing Articaine hydrochloride Epinephrine (adrenaline) 1: 100.000 injection for both groups. For patients that recieved (NIPSA) as reported by (Moreno Rodríguez and Caffesse 2017).
- After locally anesthetizing the area an apical horizontal incision on the buccal mucosa, as far as possible from the interdental papillae and marginal KT will be performed. Soft tissue will be reflected apico-coronally by a full-thickness flap showing the granulation tissue filling the bony defect after exposing the coronal limit of the intra-bony component of the defect, while the marginal tissue will be kept unaltered.
- Horizontal mattress sutures with single interrupted sutures will be placed as the second line of closure. while patients that received (M-MIST) reported by (Banthia et al. 2016a)
- Access to the defect will be gained through the tiny buccal triangular flap: from the buccal 'window' the soft tissue filling the defect (i.e. the so-called granulation tissue) will be sharply dissected from the papillary supra-crestal connective tissue and from the bony walls with a micro-blade and will be removed with a mini-curette (The soft tissue will be sharply dissected from the osseous defect)
- No interdental and/or lingual intra-sulcular incisions will be performed. The supra-crestal interdental tissues.
- Surgical flaps will be sutured to the pre-surgical level with 5-0 vicryl suture utilizing single interrupted suturing techniques that will achieve primary closure.
- Sutures will be removed 2 weeks post-surgically. Patients will be asked to discontinue mechanical tooth-brushing technique in the surgical area for 2 weeks.
- After this period, patients will be instructed to continue mechanical tooth brushing again of the treated sites using a soft toothbrush.
Patients will be recalled monthly for supportive periodontal therapy during the course of the study. And then will be recalled every six months for supportive periodontal therapy after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- • The patients will be randomly assigned into two groups: Group A (Test): Patients will receive Non-Incised Papilla Surgical Approach (NIPSA) • Group B (Control): Patients will receive Modified Minimally Invasive Surgical technique (M-MIST)
| Arm | Type | Receives |
|---|---|---|
| Modified Minimally Invasive Surgical Technique | Active comparator | Procedure: Group B (Control): Patients will receive M-MISTComparator: Modified Minimally Invasive Surgical Technique The defect will be gained through the tiny buccal triangular flap: from the buccal 'window' the soft tissue filling the defect (i.e. the so-called granulation tissue) will be sharply dissected from the papillary supra-crestal connective tissue and from the bony walls with a micro-blade and will be removed with a mini-curette (The soft tissue will be sharply dissected from the osseous defect) |
| Non- incised papilla surgical approach | Other | Procedure: Group A (Test): Patients will receive NIPSAintervention: Non- incised papilla surgical approach Apical horizontal incision on the buccal mucosa, as far as possible from the interdental papillae and marginal KT will be performed. Soft tissue will be reflected apico-coronally by a full-thickness flap showing the granulation tissue filling the bony defect after exposing the coronal limit of the intra-bony component of the defect, while the marginal tissue will be kept unaltered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Stage III periodontitis patient having at least one tooth with Two walls or combined 2- to 3-walls intraosseous defects ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- Defect not extended to a root furcation area.
- Vital teeth
- Non-smokers.
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
Key exclusion criteria (3 listed)
- Pregnancy or breast feeding.
- The presence of an orthodontic appliance.
- Teeth mobility greater than grade I.
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 |
|---|---|---|
| Group A (Test): Patients will receive NIPSApatients received Non- incised papilla surgical approache | Procedure or surgery | Non- incised papilla surgical approach |
| Group B (Control): Patients will receive M-MISTpatients received Modified Minimally Invasive Surgical Technique | Procedure or surgery | Modified Minimally Invasive Surgical Technique |
Primary outcome
Assessment of CAL gain
Time frame: baseline/ after 6 months & 1 year post-surgical
Clinical attachment Level gain (CAL) by UNC Periodontal probe (mm)
3 secondary outcomes
Assessment of PD reduction
Time frame: 1 year
gingival recession
Time frame: 1 year
radiographic bone fill.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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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 Group A (Test): Patients will receive NIPSA in people with Periodontitis, Adult, run by Cairo 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 11 inclusion and 3 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 4 Nov 2019. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of CAL gain (time frame: baseline/ after 6 months & 1 year post-surgical). 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 4 Nov 2019.