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

NCT04149834 | Unknown

• 1 other identifier: PER3-3-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis, Adult

Keywords

Intraossous defects; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Assessment of CAL gain

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

  baseline/ after 6 months & 1 year post-surgical

Secondary Outcomes (3)

• Assessment of PD reduction

  1 year

• gingival recession

  1 year

• radiographic bone fill.

  1 year

Study Arms (2)

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)

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.

Procedure: Group A (Test): Patients will receive NIPSA

Interventions

Group A (Test): Patients will receive NIPSA PROCEDURE

patients received Non- incised papilla surgical approache

Non- incised papilla surgical approach

Group B (Control): Patients will receive M-MIST PROCEDURE

patients received Modified Minimally Invasive Surgical Technique

Modified Minimally Invasive Surgical Technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Unv

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer assistant

Model Details: • 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)

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: November 4, 2019
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: October 1, 2022
• Last Updated: November 4, 2019

Record last verified: 2019-10

Locations

EG (1)