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Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement

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ClinicalTrials.gov Identifier: NCT03787342
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nada Zazou, Cairo University

Brief Summary:
Guided Bone Regeneration (GBR) is a reliable method to augment insufficient bone volume for implant placement. Membrane exposure is a major complication which is avoided by tension free primary closure. Classically Periosteal Releasing Incision (PRI) is performed to advance the flap. The aim of this trial is to compare Double Flap Incision (DFI), Modified Periosteal Releasing Incision (MPRI) & Coronally Advanced Lingual Flap (CALF) to PRI in terms of flap advancement, postoperative pain & swelling, membrane exposure and the amount of bone gain clinically and radiographically in GBR procedures.

Condition or disease Intervention/treatment Phase
Flap Advancement Procedure: Double Flap Incision Procedure: Modified Periosteal Releasing Incision Procedure: Coronally Advanced Lingual Flap Procedure: Periosteal releasing incision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three Groups of intervention compared to one group of comparator. Each group contains 10 patients.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Care provider and investigator cannot be blinded as they are involved in the surgical procedure so blinding is not feasible.
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Controlled Clinical Trial
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: DFI "Double Flap Incision"
A full-thickness crestal incision will be made over the edentulous ridge, and then one partial-thickness vertical incision will be made on the buccal side. A partial-thickness flap will be raised first to separate the mucosal layer from the overlying periosteum. Subsequently, the periosteal layer will be elevated to expose the underlying alveolar process. Xenograft and Ti-mesh will be used to augment the defective site then periosteal flap will be sutured first, with periosteal sutures securing the regenerative site. Then the mucosal flap will be closed.
Procedure: Double Flap Incision
A full-thickness crestal incision will be made over the edentulous ridge, and then one partial-thickness vertical incision will be made on the buccal side. A partial-thickness flap will be raised first to separate the mucosal layer from the overlying periosteum. Subsequently, the periosteal layer will be elevated to expose the underlying alveolar process. Xenograft and Ti-mesh will be used to augment the defective site then periosteal flap will be sutured first, with periosteal sutures securing the regenerative site. Then the mucosal flap will be closed.
Other Name: DFI

Experimental: MPRI "Modified PRI"
A full-thickness muco-periosteal flap is reflected on the buccal side (crestal incision and two vertical releasing incisions). Near the base of mucoperiosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The shallow incision helps in preventing damage to the submucosal layer. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the "lateral stretching" of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade with sweeping motion to allow flap advancement.
Procedure: Modified Periosteal Releasing Incision
A full-thickness muco-periosteal flap is reflected on the buccal side (crestal incision and two vertical releasing incisions). Near the base of mucoperiosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The shallow incision helps in preventing damage to the submucosal layer. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the "lateral stretching" of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade with sweeping motion to allow flap advancement.
Other Name: MPRI

Experimental: CALF "Coronally Advanced Lingual Flap"
A full-thickness crestal incision will be performed in the keratinized tissue from the distal surface of the more distal tooth to the retromolar pad. The flap design will be continued intrasulcularly on both vestibular and lingual sides of the mesial portion of the flap, buccally, it will be finished with a vertical releasing incision. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. Then, using a blunt instrument it will be localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. The blunt instrument will be inserted below this connective band, and, with gentle traction in the coronal direction, this muscular insertion will be detached from the lingual flap.
Procedure: Coronally Advanced Lingual Flap
A full-thickness crestal incision will be performed in the keratinized tissue from the distal surface of the more distal tooth to the retromolar pad. The flap design will be continued intrasulcularly on both vestibular and lingual sides of the mesial portion of the flap, buccally, it will be finished with a vertical releasing incision. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. Then, using a blunt instrument it will be localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. The blunt instrument will be inserted below this connective band, and, with gentle traction in the coronal direction, this muscular insertion will be detached from the lingual flap.
Other Name: CALF

Active Comparator: PRI "Periosteal Releasing Incision"
A full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side and a full thickness flap will be raised. Xenograft and Ti-mesh will be used to augment the defective site then incremental incisions of 1-3 mm into the periosteum and submucosa will be used to advance the muco-periosteal flap. The flap will then be sutured as a whole unit.
Procedure: Periosteal releasing incision



Primary Outcome Measures :
  1. Flap advancement [ Time Frame: Intraoperative ]
    Flap advancement in millimeters will be measured as the difference before and after Double flap Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, and Periosteal Releasing Incision in millimeters using periodontal probe.


Secondary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 7 days postoperatively ]
    Pain will be recorded using Numerical Rating scale (NRS). It is a scale from 0 to 10. 0 indicates no pain and 10 indicates severe pain.

  2. Postoperative Swelling [ Time Frame: 7 days postoperatively ]
    will be recorded using Visual Analogue Scale (VAS). It is a scale from 0 to 4. 0 indicates no swelling while 4 indicates severe extra-oral swelling.


Other Outcome Measures:
  1. Postoperative membrane exposure [ Time Frame: will be evaluated at 1, 2, 3, 4, 12, 24 weeks postoperative ]
    Measure the dimensions of the exposure using a periodontal probe in millimeters.

  2. Bone width gain [ Time Frame: preoperative & 6 months postoperative. ]
    The amount of bone gain will be measured before and after in millimeters on a cone beam CT & Clinically using bone caliper.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Partially edentulous patients in the mandibular posterior region.
  2. Patients with healthy systemic condition.
  3. Insufficient ridge width (< 5mm).
  4. Presence of proper inter-arch space for placement of the implant prosthetic part.
  5. Adequate soft tissue biotype (≥ 2mm).
  6. No clinical evidence of active periodontal disease or oral infections.

Exclusion Criteria:

  1. Patients with systemic conditions that may interfere with the results of the study.
  2. Patients with local pathological defects related to the area of interest.
  3. Unmotivated, uncooperative patients with poor oral hygiene.
  4. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
  5. History of bone associated diseases or medication affecting bone metabolism e.g.; bisphosphonate treatment.
  6. History of radiation therapy in the head or neck region.
  7. Current anti-tumor chemotherapy.
  8. Pregnancy.
  9. Inflammatory and autoimmune diseases of the oral cavity.

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): NCT03787342


Contacts
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Contact: Nada Zazou, Masters +201224016945 drzazou@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 12613
Contact: Nada Zazou, Masters         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Nada Zazou, Masters Cairo University

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Responsible Party: Nada Zazou, Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA)., Cairo University
ClinicalTrials.gov Identifier: NCT03787342     History of Changes
Other Study ID Numbers: PERIO3:7:1
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nada Zazou, Cairo University:
Periosteal Releasing Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Double Flap Incision, Titanium mesh, GBR

Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries