Alveolar Bone LossNCT03466840
Comparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients
A study testing The coronally advanced lingual flap and Modified periosteal releasing Incision in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- The coronally advanced lingual flap and Modified periosteal releasing Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 25 Aug 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, 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 (≥ 2 mm).
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh.
Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)
Read the detailed description
Clinical Assessment and Comparison of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Clinical Trial
- Conditions
- Alveolar Bone Loss
- Being tested
- The coronally advanced lingual flap, Modified periosteal releasing Incision
- Keywords
- Ridge Augmentation, Titanium mesh, Flap advancement
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The coronally advanced lingual flapProcedure or surgery
: A full-thickness crestal incision is performed from the distal surface of the more distal tooth to retromolar pad and finishing with releasing incision. On the lingual side, a full-thickness muco-periosteal flap was elevated until reaching mylohyoid line. Then using a blunt instrument, it was localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. It is inserted into the inner part of the lingual flap about 5mm from the crest in an apical direction. The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe", the amount of advancement is measured.
Modified periosteal releasing IncisionProcedure or surgery
A full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. 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, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured.
| Study group | Role | What they receive |
|---|---|---|
| The Coronally Advanced Lingual Flap | Experimental | On the lingual side of mandible, a full-thickness muco-periosteal flap is elevated until reaching mylohyoid line. Using a blunt instrument, a connective tissue band is localized continuing with the epimysium of the mylohyoid muscle and is inserted into the inner part of the lingual flap . The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe" the amount of advancement is measured. Receives: Procedure: The coronally advanced lingual flap |
| Modified periosteal releasing Incision | Active comparator | A full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. 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, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured Receives: Procedure: Modified periosteal releasing Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap advancement
Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.
Measured: "10 minutes"
Secondary outcomes (4)
Postoperative Pain
Postoperative Pain will be recorded using Numerical Rating scale (NRS) The scores will be recorded postoperatively by the patient for the seven days of observation.
Measured: 1 Week
Postoperative membrane exposure
Postoperative membrane exposure will be evaluated at 1, 2, 3, 4, 12 weeks using a periodontal probe in millimeters.
Measured: 12 Weeks
bone density
bone density will before and after with cone beam computed tomography (CBCT)
Measured: 12 Weeks
postoperative swelling
postoperative swelling will be recorded using descriptive four point scale(Penarrocha et al.2006).The scores will be recorded postoperatively by the patient for the seven days of observation.
Measured: "1 week"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jan 2018
- Primary completion1 Jul 2018 (estimated)
- Study completion25 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Fathi Messalam Diab, Cairo University
- Investigators
- Egypt Recruiting, Principal investigator, Cairo, Egypt, 02
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466840
- Sponsor's protocol ID
- cebc. cairouniversity
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh.
- ClinicalTrials.gov ID
- NCT03466840
- Acronym / sponsor ID
- cebc. cairouniversity
- Conditions
- Alveolar Bone Loss
- Keywords
- Ridge Augmentation, Titanium mesh, Flap advancement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 25 Aug 2018 (estimated)
- First posted
- 15 Mar 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.
Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)
Detailed description
Clinical Assessment and Comparison of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Coronally Advanced Lingual Flap | Experimental | Procedure: The coronally advanced lingual flapOn the lingual side of mandible, a full-thickness muco-periosteal flap is elevated until reaching mylohyoid line. Using a blunt instrument, a connective tissue band is localized continuing with the epimysium of the mylohyoid muscle and is inserted into the inner part of the lingual flap . The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe" the amount of advancement is measured. |
| Modified periosteal releasing Incision | Active comparator | Procedure: Modified periosteal releasing IncisionA full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. 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, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 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 (≥ 2 mm).
Key exclusion criteria (4 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.
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 |
|---|---|---|
| The coronally advanced lingual flap: A full-thickness crestal incision is performed from the distal surface of the more distal tooth to retromolar pad and finishing with releasing incision. On the lingual side, a full-thickness muco-periosteal flap was elevated until reaching mylohyoid line. Then using a blunt instrument, it was localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. It is inserted into the inner part of the lingual flap about 5mm from the crest in an apical direction. The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe", the amount of advancement is measured. | Procedure or surgery | The Coronally Advanced Lingual Flap |
| Modified periosteal releasing IncisionA full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. 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, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured. | Procedure or surgery | Modified periosteal releasing Incision |
Primary outcome
Flap advancement
Time frame: "10 minutes"
Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.
4 secondary outcomes
Postoperative Pain
Time frame: 1 Week
Postoperative membrane exposure
Time frame: 12 Weeks
bone density
Time frame: 12 Weeks
postoperative swelling
Time frame: "1 week"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Alveolar Bone Loss
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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.
Egypt Recruiting principal investigator
Cairo, Egypt, 02
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The coronally advanced lingual flap and Modified periosteal releasing Incision in people with Alveolar Bone Loss, 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Fa Diab, master (01222563478 ext. +02, diab.noha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap advancement (time frame: "10 minutes"). 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 15 Mar 2018.