Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562039
Recruitment Status : Unknown
Verified August 2018 by Ahmed Ibrahim, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Ibrahim, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is aiming to compare the clinical and radiographic outcomes after complete versus incomplete removal of granulation tissue during modified minimally invasive surgical technique for management of periodontal intrabony defects in patients with chronic periodontitis.

Condition or disease Intervention/treatment Phase
Periodontal Bone Loss Procedure: M-MIST Not Applicable

Detailed Description:

Periodontal surgery has been expanding in the world of dentistry throughout the past years, as new techniques are emerging to treat the different and complex periodontal disorders. Surgical procedures in dentistry have undergone major changes to minimize invasiveness. In addition, novel instruments and materials have been made to suit the evolution of the surgical procedures (Cortellini. 2012).

Teeth with deep pockets associated with deep intra-bony defects are a clinical challenge for periodontists, where periodontal regeneration has been proven to be effective in managing the treatment of one-, two-, and three-wall intra-bony defects (Needleman and Tucker 2012;Needleman. 2015).

Harrel and Rees (1995) were the first to introduce the term minimally invasive surgery (MIS). MIS is used to describe the use of smaller and more precise surgical procedures that are possible by using of magnifying instruments, such as operating microscopes and microsurgical instruments and materials (Cortellini. 2012).

The rationale for the development of minimally invasive surgical technique (MIST) includes: reduction of trauma during the surgery, increase in flap and wound stability, improvement of wound primary closure, reduction of surgical time, and minimization of intra-operative and post-operative patient discomfort (Cortellini. 2007).

With the use of MIST, Cortellini and Tonneti (2009) confirmed blood clot protection with the aspects of wound and blood clot stability and primary wound closure.

An enhancement of MIST, the modified minimally invasive surgical technique (M-MIST), has been introduced by Cortellini in 2009 to further reduce the surgical invasiveness, with three major objectives in mind: (1) minimize the interdental tissue tendency to collapse providing space provision for regeneration, (2) enhance the wound/soft tissue stability and (3) reduce patient morbidity.

Some authors evaluated the use of various regenerative material in MIST and M-MIST e.g. Enamel matrix derivative (Cortellini 2007) PDGF-bb (Cosyn et al. 2012) and collagen enriched bovine derived xeno-graft (Mishra et al., 2013). Cortellini (2011) also, noted that the use of regenerative material is not necessary with M-MIST.

Hung et al, (2012) reported that granulation tissue could contain progenitor stem cells which are very important components needed for periodontal tissue regeneration.

Moreover, Park et al. (2011) assumed that the inflamed granulation tissue could be used to regenerate lost tissues in the same individual in other defective sites according to its regenerative potential.

All the previous data raised an important question about the necessity to remove granulation tissues in periodontal regenerative techniques: Is complete removal of granulation tissue in M-MIST is mandate for treating isolated intra-bony defects for better healing?

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Evaluation of Intra Bony Defects Following Complete Versus Incomplete Removal of Granulation Tissue in Modified Minimally Invasive Surgical Technique (M-MIST). A Randomized Controlled Clinical Trial.
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: M-MIST (group A)
M-MIST(incomplete granulation tissue removal)
 Procedure: M-MIST
minimal invasive surgical technique without thorough removal of granulation tissue
Active Comparator: M-MIST (group B)
conventional M-MIST.
 Procedure: M-MIST
minimal invasive surgical technique without thorough removal of granulation tissue


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. changes in clinical attachment level [ Time Frame: at baseline then 3 , 6 and 9 months ]
    It is the distance from the cement-enamel junction to the depth of the pocket.


Secondary Outcome Measures :
  1. changes in pocket probing depth [ Time Frame: at baseline then at 3,6 and 9 months ]
    distance from the depth of the pocket to the gingival margin

  2. changes in gingival recession [ Time Frame: at baseline then at 3,6 and 9 months ]
    distance of the exposed root surface from the cemento-enamel junction to the gingival margin

  3. amount of bone fill [ Time Frame: at baseline then at 6 and 9 months ]
    difference in bone fill in standardized periapical radiograogh

  4. patient pain and discomfort [ Time Frame: at day of the surgery then at 1 , 3 and 7 days post-surgery ]
    by giving the patient a questionnaire to fill

  5. patient satisfaction [ Time Frame: 9 months post-surgery ]
    by giving the patient a questionnaire to fill


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • - Medically free patients attending the outpatient clinic.
  • Both sexes will be included.
  • Age range from 25 - 55.
  • Patients with moderate to advanced chronic periodontitis with pockets ≥ 5 mm 6-8 weeks after phase I (non-surgical) therapy.
  • Vertical 2 or 3 walls Intra-bony defects ≥ 3mm.
  • Perform and maintain good oral hygiene.
  • Able to come for the follow up appointment's needed

Exclusion Criteria:

  • - Smokers.
  • Pregnant patients.
  • Uncooperative patients with poor oral hygiene.
  • Multirooted teeth with furcation involvement.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562039


Contacts
Layout table for location contacts
Contact: Ahmed Ibrahim, BDS +201066842084 ah_jb5@hotmail.com
Contact: Enjy Ahmed, Ass. prof. +201018941119 nourhany08@gmail.com

Locations
Layout table for location information
Egypt
Cairo University
Cairo, Manyal, Egypt
Contact: Hano Nahass, PhD    01000252603    nahass77@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Hani Nahass, Ass.prof. Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:
Harrel SK. 1999. "A Minimally Invasive Surgical Approach for Periodontal Regeneration: Surgical Technique and Observations. J Periodontol 70: 1547-1557." Hung, Tzu-yuan, Hsiang-chun Lin, and Ying-jen Chan. 2012. "Isolating Stromal Stem Cells from Periodontal Granulation Tissues," 1171-80. doi:10.1007/s00784-011-0600-5. J-c, Park, Kim J-m, Jung I-h, Kim Jc, Choi S-h, Cho K-s, Kim C-s Isolation, and Chang-sung Kim. 2011. "Isolation and Characterization of Human Periodontal Ligament ( PDL ) Stem Cells ( PDLSCs ) from the Inflamed PDL Tissue : In Vitro and in Vivo Evaluations" 18: 721-31. doi:10.1111/j.1600-051X.2011.01716.x. Lindhe and Nyman, periodontology Clinical. 1985. "Scaling and Granulation Tissue Removal in Periodontal Therapy *," no. 1983: 374-88. Needleman, I. 2015. "Clinical Concepts for Regenerative Therapy in Intrabony Defects" 68: 282-307.

Layout table for additonal information
Responsible Party: Ahmed Ibrahim, principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03562039    
Other Study ID Numbers: 125896
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
 Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases