- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03787342
Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement
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
Study Overview
Status
Conditions
Detailed Description
Study setting:
The patients will be assigned from the outpatient clinic of "The Faculty of Oral and Dental Medicine, Cairo University". Surgical procedures will be held in the periodontology clinic of the faculty. The recruited sample would be from the Egyptian urban and rural population.
Eligibility Criteria:
Inclusion criteria:
- Partially edentulous patients in the mandibular posterior region.
- Patients with healthy systemic condition.
- Insufficient ridge width (< 5mm).
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Adequate soft tissue biotype (≥ 2mm).
- No clinical evidence of active periodontal disease or oral infections.
Exclusion Criteria:
- Patients with systemic conditions that may interfere with the results of the study.
- Patients with local pathological defects related to the area of interest.
- Unmotivated, uncooperative patients with poor oral hygiene.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
- History of bone associated diseases or medication affecting bone metabolism e.g.; bisphosphonate treatment.
- History of radiation therapy in the head or neck region.
- Current anti-tumor chemotherapy.
- Pregnancy.
- Inflammatory and autoimmune diseases of the oral cavity.
Interventions:
Pre-surgical phase:
- Medical History Questionnaire (MHQ): Patients will be interviewed to gather information regarding general and oral health and MHQ will be filled by the patient and will be kept among patient's record file.
Clinical intra-oral examination
- To ensure that the patient fulfills the previously mentioned defect-inclusion criteria.
- Thorough intra-oral examination including teeth for caries, fracture, missing, or hopeless teeth and gingival-mucosal tissues for gingivitis, periodontitis, or oral lesions.
- Referral for consultation or treatment if needed before the surgical phase.
- If the patient meets the clinical selection criteria then radiographic examination will be held. CBCT will be performed for adequate evaluation of bone width and density and to be kept as a record for postoperative comparison.
- Patients must sign an informed consent to clinical research previously approved by the Faculty of Oral and Dental Medicine, Cairo University.
- Eligible patients will be randomized before being enrolled in the study.
Surgical phase:
The patients will be assigned into four groups, all undergoing GBR using Ti- mesh and Xenograft as follow:
- Group A: Flap advancement will be achieved using the DFI and this group will be assigned as a test group.
- Group B: Flap advancement will be achieved using the MPRI and this group will be assigned as a test group.
- Group C: Flap advancement will be achieved using the CALF and this group will be assigned as a test group.
- Group D: Flap advancement will be achieved using the PRI and this group will be assigned as the control group.
Surgical Protocol:
The surgical procedures will be performed under local anesthesia
Group A:
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.
Group B:
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. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile and thus facilitates flap advancement (approximately 3-5mm). Xenograft and Ti-mesh will be used to augment the defective site.
Group C:
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.
Group D:
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.
Post-surgical instructions:
- 1 g of Amoxicilin twice a day for 6 days with analgesic and anti-inflammatory drug, every 8 hours for 4 to 5 days, and 0.2% chlorexidine rinse 1min three times a day for 2 weeks, starting the day after surgery.
- Immediately after surgery, ice packs will be applied onto the treated area and it is recommended that they be kept in place for at least 4 h.
- Avoid tooth brushing especially at surgical sites, and soft diet to avoid trauma to the site of surgery for the first 3 weeks.
- Subsequent visits will be scheduled for healing assessment and measurement recording and if necessary, a professional supra-gingival prophylaxis will be performed.
- Sutures were removed after 2 week.
- A removable prosthesis was never allowed, during healing, to avoid trans-mucosal pressure on the operated area.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 12613
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Partially edentulous patients in the mandibular posterior region.
- Patients with healthy systemic condition.
- Insufficient ridge width (< 5mm).
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Adequate soft tissue biotype (≥ 2mm).
- No clinical evidence of active periodontal disease or oral infections.
Exclusion Criteria:
- Patients with systemic conditions that may interfere with the results of the study.
- Patients with local pathological defects related to the area of interest.
- Unmotivated, uncooperative patients with poor oral hygiene.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
- History of bone associated diseases or medication affecting bone metabolism e.g.; bisphosphonate treatment.
- History of radiation therapy in the head or neck region.
- Current anti-tumor chemotherapy.
- Pregnancy.
- Inflammatory and autoimmune diseases of the oral cavity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
|
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.
|
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 Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days postoperatively
|
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.
|
7 days postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
will be evaluated at 1, 2, 3, 4, 12, 24 weeks postoperative
|
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.
|
preoperative & 6 months postoperative.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nada Zazou, Masters, Cairo University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERIO3:7:1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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