Flap AdvancementNCT03787342
Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement
A study testing Double Flap Incision, Modified Periosteal Releasing Incision and Coronally Advanced Lingual Flap in people with Flap Advancement, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Flap Advancement
- What is being tested?
- Double Flap Incision, Modified Periosteal Releasing Incision and Coronally Advanced Lingual Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2016to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Current anti-tumor chemotherapy.
- Pregnancy.
- Inflammatory and autoimmune diseases of the oral cavity.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Flap Advancement
- Being tested
- Double Flap Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Periosteal releasing incision
- Keywords
- Periosteal Releasing Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Double Flap Incision, Titanium mesh, GBR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Flap IncisionProcedure or surgery
Also called DFI
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.
Modified Periosteal Releasing IncisionProcedure or surgery
Also called MPRI
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.
Coronally Advanced Lingual FlapProcedure or surgery
Also called CALF
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.
Periosteal releasing incisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| DFI "Double Flap Incision" | Experimental | 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. Receives: Procedure: Double Flap Incision |
| MPRI "Modified PRI" | Experimental | 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. Receives: Procedure: Modified Periosteal Releasing Incision |
| CALF "Coronally Advanced Lingual Flap" | Experimental | 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. Receives: Procedure: Coronally Advanced Lingual Flap |
| PRI "Periosteal Releasing Incision" | Active comparator | 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. Receives: Procedure: Periosteal releasing incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap advancement
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.
Measured: Intraoperative
Secondary outcomes (2)
Postoperative Pain
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.
Measured: 7 days postoperatively
Postoperative Swelling
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.
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Dec 2016
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flap AdvancementStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three Groups of intervention compared to one group of comparator. Each group contains 10 patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Zazou, Cairo University
- Investigators
- Nada Zazou, Masters, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787342
- Sponsor's protocol ID
- PERIO3:7:1
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03787342
- Acronym / sponsor ID
- PERIO3:7:1
- Conditions
- Flap Advancement
- Keywords
- Periosteal Releasing Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Double Flap Incision, Titanium mesh, GBR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Three Groups of intervention compared to one group of comparator. Each group contains 10 patients.
| Arm | Type | Receives |
|---|---|---|
| DFI "Double Flap Incision" | Experimental | Procedure: Double Flap IncisionA 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. |
| MPRI "Modified PRI" | Experimental | Procedure: Modified Periosteal Releasing IncisionA 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. |
| CALF "Coronally Advanced Lingual Flap" | Experimental | Procedure: Coronally Advanced Lingual FlapA 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. |
| PRI "Periosteal Releasing Incision" | Active comparator | Procedure: Periosteal releasing incisionA 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Flap IncisionAlso: DFIA 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 or surgery | DFI "Double Flap Incision" |
| Modified Periosteal Releasing IncisionAlso: MPRIA 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 or surgery | MPRI "Modified PRI" |
| Coronally Advanced Lingual FlapAlso: CALFA 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 or surgery | CALF "Coronally Advanced Lingual Flap" |
| Periosteal releasing incision | Procedure or surgery | PRI "Periosteal Releasing Incision" |
Primary outcome
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.
2 secondary outcomes
Postoperative Pain
Time frame: 7 days postoperatively
Postoperative Swelling
Time frame: 7 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
Fistula Perianal
Recruiting
A Hinge Flap to Reinforce Buccal Advancement Flap
Oroantral Fistula
Recruiting
Evaluation of Horizontal Bone Gain of Ridge Augmentation Using Customized Porous Zirconia Shell.
Horizontal Ridge Deficiency, Deficient Alveolar Bone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Zazou, Masters principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Flap Incision, Modified Periosteal Releasing Incision and Coronally Advanced Lingual Flap in people with Flap Advancement, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap advancement (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.