search
Back to results

Clinical and Radiographic Evaluation of NIPSA Versus M-MIST in Treatment of Intra-osseous Defects

Primary Purpose

Periodontitis, Adult

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group A (Test): Patients will receive NIPSA
Group B (Control): Patients will receive M-MIST
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Adult focused on measuring Intraossous defects, Periodontitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • Pregnancy or breast feeding.
  • The presence of an orthodontic appliance.
  • Teeth mobility greater than grade I.

Sites / Locations

  • Cairo UnvRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Modified Minimally Invasive Surgical Technique

Non- incised papilla surgical approach

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Assessment of CAL gain
Clinical attachment Level gain (CAL) by UNC Periodontal probe (mm)

Secondary Outcome Measures

Assessment of PD reduction
UNC Perioodntal probe (mm)
gingival recession
UNC Perioodntal probe (mm)
radiographic bone fill.
Linear measurements standardized periapical radiograph (mm)

Full Information

First Posted
October 20, 2019
Last Updated
October 31, 2019
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04149834
Brief Title
Clinical and Radiographic Evaluation of NIPSA Versus M-MIST in Treatment of Intra-osseous Defects
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
Keywords
Intraossous defects, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Single blinded: Blinding of the participants is not applicable. Blinding of the operator is not applicable. Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Minimally Invasive Surgical Technique
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Non- incised papilla surgical approach
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group A (Test): Patients will receive NIPSA
Intervention Description
patients received Non- incised papilla surgical approache
Intervention Type
Procedure
Intervention Name(s)
Group B (Control): Patients will receive M-MIST
Intervention Description
patients received Modified Minimally Invasive Surgical Technique
Primary Outcome Measure Information:
Title
Assessment of CAL gain
Description
Clinical attachment Level gain (CAL) by UNC Periodontal probe (mm)
Time Frame
baseline/ after 6 months & 1 year post-surgical
Secondary Outcome Measure Information:
Title
Assessment of PD reduction
Description
UNC Perioodntal probe (mm)
Time Frame
1 year
Title
gingival recession
Description
UNC Perioodntal probe (mm)
Time Frame
1 year
Title
radiographic bone fill.
Description
Linear measurements standardized periapical radiograph (mm)
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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). Exclusion Criteria: Pregnancy or breast feeding. The presence of an orthodontic appliance. Teeth mobility greater than grade I.
Facility Information:
Facility Name
Cairo Unv
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo Unv
Phone
0223634965
Email
Perio@dentistry.cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Clinical and Radiographic Evaluation of NIPSA Versus M-MIST in Treatment of Intra-osseous Defects

We'll reach out to this number within 24 hrs