Atrophic Anterior Alveolar RidgeNCT05844540
L- Shape Symphyseal Autogenous Bone Block for Alveolar Ridge Augmentation in Anterior Maxilla and Mandible
A study testing harvesting bone block, Recipient site preparation and implant insertion in people with Atrophic Anterior Alveolar Ridge, run by Mansoura University at 1 site in Egypt.
Trial summary
the aim of this study was to assess both horizontal and vertical alveolar bone augmentation for sever atrophied anterior maxilla and mandible, using L- shape autogenous bone block harvested from the symphysis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Anterior Alveolar Ridge
- What is being tested?
- harvesting bone block, Recipient site preparation and implant insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2021to 21 Aug 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Missed one or more upper or lower anterior teeth.
- alveolar ridge with horizontal and vertical bone loss (class III according to Seibert et al(1983) classification).
- age 18 to 45 years.
- healthy oral mucosa, at least 3 mm keratinized mucosa.
- no systemic diseases or drugs that affect bone healing.
- no systemic or local conditions that contraindicate bone grafting or surgery.
Who cannot join
- Patients with disturbed occlusion, inadequate inter-arch space.
- patients with parafunction habits as bruxism or clenching.
- pregnancy.
- smokers.
- poor oral hygiene.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Eldakahlia, 35516
About this study
the aim of this study was to assess both horizontal and vertical alveolar bone augmentation for sever atrophied anterior maxilla and mandible, using L- shape autogenous bone block harvested from the symphysis. eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically. Horizontal and vertical bone gain was measured by CBCT immediate postoperative and at 6months after grafting.
Read the detailed description
A total of 11 partially edentulous patients needing extensive horizontal and vertical bone augmentation in the anterior maxilla or mandible were included in this study. The patients were recruited from the Outpatient Clinic of Oral and Maxillofacial Department, Faculty of Dentistry, Mansoura University.
Before the surgical operation, all patients were informed about the treatment options, the nature of the operation, and the probable postoperative sequelae. An informed consent was signed from each patient.
Preoperative assessment
- Patients' medical status were carefully evaluated.
- A thorough intraoral examination was done to evaluate oral hygiene, occlusion, and mucosa that covers the recipient and donor sites.
- Preoperative CBCT was done for each patient to evaluate bone width and height in both the recipient and donor sites.
Surgical procedures Prophylactic antibiotic 600 mg Clindamycin (Clindam, Sigma, Egypt) was administered 1 hour before surgery. A thorough mouth rinsing using Chlorhexidine mouth wash (Hexitol, Adco, Egypt) for about 1 min was done immediately before surgery.
Harvesting procedure of the symphysis bone block:
Under local anesthesia, a sulcular incision was performed between lower right and left second premolars with an oblique incision distal to each one. After that, a full thickness mucoperiosteal flap was elevated to expose the anterior mandible including the entire symphysis and both mental nerves. By using piezo-surgery unit, a rectangular bone block was harvested from the symphysis about 8mm in depth and 2mm wider than the recipient site to allow for contouring. The bone cuts were performed 5mm far from the apices of the anterior teeth, mental foramina, and inferior border of the mandible. Finally, thin curved osteotomes was used to detach the bone blocks. The harvested bone block was trimmed to form L-shape block and kept in normal saline. After hemostasis, the flap was closed with 4/0 vicryl interrupted sutures.
Recipient site preparation:
At the maxillary recipient site, after induction of local anesthesia, a mid-crestal incision that continued in the sulcus for two teeth on either side of the defect with bilateral oblique incisions were performed. After that, the full thickness mucoperiosteal flap was elevated. While for mandibular recipient site, it was the same flap used for harvesting symphyseal bone block. For both upper or lower recipient sites, perforations (bone marrow penetration) were done to the recipient site by using a fissure surgical bur. The L-shape block graft was trimmed to obtain optimal adaptation to the recipient site, then it was fixed to the residual ridge with two 1.5mm self-tapping titanium screws. After attaining graft stability, any sharp edges were smoothed and any gap between the graft and underlying alveolar bone was filled with particulate bone curetted from the donner site. Finally, the flap was relaxed by periosteal incisions and blunt muscle dissection from the anterior maxilla or mandible to obtain a primary tension free closure using 4/0 vicryl interrupted and horizontal mattress sutures.
Postsurgical instructions:
Patients were instructed to avoid any wound trauma, and apply ice packs on the host and recipient surgical sites 20min/ hour for the first day after surgery. Proper oral hygiene should be maintained by mouth rinsing with chlorhexidine mouth wash 3times/ day for 1 week. Diclofenac potassium 50mg (Cataflam, Novartis, Switzerland) anti-inflammatory analgesic was prescribed as needed. Clindamycin 300mg twice daily was prescribed for 7days.
Implant insertion:
After 6months, the surgical site was opened to remove fixation screws and insert dental implants, and the final restoration was done 4months after implant insertion.
Evaluation: the patients were scheduled at 3days, 14days, 3months, and 6months postoperatively to evaluate:
- Conditions
- Atrophic Anterior Alveolar Ridge
- Being tested
- harvesting bone block, Recipient site preparation, implant insertion
- Keywords
- L- Shape autogenous bone block, symphysis, alveolar ridge augmentation, anterior maxilla and mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harvesting bone blockProcedure or surgery
Also called piezo-surgery block harvesting
Under local anesthesia, a sulcular incision was performed between lower right and left second premolars with an oblique incision distal to each one. After that, a full thickness mucoperiosteal flap was elevated to expose the anterior mandible including the entire symphysis and both mental nerves. By using piezo-surgery unit (Surgic Touch, Woodpecker, China), a rectangular bone block was harvested from the symphysis about 8mm in depth and 2mm wider than the recipient site to allow for contouring. The bone cuts were performed 5mm far from the apices of the anterior teeth, mental foramina, and inferior border of the mandible. Finally, thin curved osteotomes was used to detach the bone blocks. The harvested bone block was trimmed to form L-shape block and kept in normal saline. After hemostasis, the flap was closed with 4/0 vicryl interrupted sutures.
Recipient site preparationProcedure or surgery
At the maxillary recipient site, after induction of local anesthesia, a mid-crestal incision that continued in the sulcus for two teeth on either side of the defect with bilateral oblique incisions were performed. After that, the full thickness mucoperiosteal flap was elevated. While for mandibular recipient site, it was the same flap used for harvesting symphyseal bone block. For both upper or lower recipient sites, perforations (bone marrow penetration) were done to the recipient site by using a fissure surgical bur. The L-shape block graft was trimmed to obtain optimal adaptation to the recipient site, then it was fixed to the residual ridge with two 1.5mm self-tapping titanium screws. After attaining graft stability, any sharp edges were smoothed and any gap between the graft and underlying alveolar bone was filled with particulate bone curetted from the donner site.
implant insertionProcedure or surgery
Implant insertion:
After 6months, the surgical site was opened to remove fixation screws and insert dental implants, and the final restoration was done 4months after implant insertion.
| Study group | Role | What they receive |
|---|---|---|
| harvesting and augmentation of bone block | Other | autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically. Receives: Procedure: harvesting bone block; Procedure: Recipient site preparation; Procedure: implant insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale for pain measurement
Pain intensity was measured at three days after surgery on a 0 to 10 numerical rating scale in which 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = the worst pain imaginable.
Measured: 3 days post-surgery
infection and dehiscence of soft tissue
This was determined clinically by presence=1 or absence=0, of pus formation or graftb exposure.
Measured: with in 6 months
questionnaire for sensory disturbance
This was assessed by patients' complaint (patient questionnaire) to determine any change in subjective sensation in the lower lip, chin and mental area. if there is pain or not. if there is numbness or not.
Measured: with in 6 months
width of the alveolar ridge
CBCT cross section view was used for evaluation of alveolar ridge width and preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.
Measured: immediate post-operative and after 6 months
height of the alveolar ridge
CBCT cross section view was used for evaluation of alveolar height preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.
Measured: immediate post-operative and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start12 Feb 2021
- Primary completion5 Jun 2022
- Study completion21 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Anterior Alveolar RidgeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844540
- Sponsor's protocol ID
- A015010222
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L- Shape Symphyseal Autogenous Bone Block for Alveolar Ridge Augmentation in Anterior Maxilla and Mandible
- ClinicalTrials.gov ID
- NCT05844540
- Acronym / sponsor ID
- A015010222
- Conditions
- Atrophic Anterior Alveolar Ridge
- Keywords
- L- Shape autogenous bone block, symphysis, alveolar ridge augmentation, anterior maxilla and mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 21 Aug 2022 (actual)
- First posted
- 6 May 2023 (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.
the aim of this study was to assess both horizontal and vertical alveolar bone augmentation for sever atrophied anterior maxilla and mandible, using L- shape autogenous bone block harvested from the symphysis. eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically. Horizontal and vertical bone gain was measured by CBCT immediate postoperative and at 6months after grafting.
Detailed description
A total of 11 partially edentulous patients needing extensive horizontal and vertical bone augmentation in the anterior maxilla or mandible were included in this study. The patients were recruited from the Outpatient Clinic of Oral and Maxillofacial Department, Faculty of Dentistry, Mansoura University.
Before the surgical operation, all patients were informed about the treatment options, the nature of the operation, and the probable postoperative sequelae. An informed consent was signed from each patient.
Preoperative assessment
- Patients' medical status were carefully evaluated.
- A thorough intraoral examination was done to evaluate oral hygiene, occlusion, and mucosa that covers the recipient and donor sites.
- Preoperative CBCT was done for each patient to evaluate bone width and height in both the recipient and donor sites.
Surgical procedures Prophylactic antibiotic 600 mg Clindamycin (Clindam, Sigma, Egypt) was administered 1 hour before surgery. A thorough mouth rinsing using Chlorhexidine mouth wash (Hexitol, Adco, Egypt) for about 1 min was done immediately before surgery.
Harvesting procedure of the symphysis bone block:
Under local anesthesia, a sulcular incision was performed between lower right and left second premolars with an oblique incision distal to each one. After that, a full thickness mucoperiosteal flap was elevated to expose the anterior mandible including the entire symphysis and both mental nerves. By using piezo-surgery unit, a rectangular bone block was harvested from the symphysis about 8mm in depth and 2mm wider than the recipient site to allow for contouring. The bone cuts were performed 5mm far from the apices of the anterior teeth, mental foramina, and inferior border of the mandible. Finally, thin curved osteotomes was used to detach the bone blocks. The harvested bone block was trimmed to form L-shape block and kept in normal saline. After hemostasis, the flap was closed with 4/0 vicryl interrupted sutures.
Recipient site preparation:
At the maxillary recipient site, after induction of local anesthesia, a mid-crestal incision that continued in the sulcus for two teeth on either side of the defect with bilateral oblique incisions were performed. After that, the full thickness mucoperiosteal flap was elevated. While for mandibular recipient site, it was the same flap used for harvesting symphyseal bone block. For both upper or lower recipient sites, perforations (bone marrow penetration) were done to the recipient site by using a fissure surgical bur. The L-shape block graft was trimmed to obtain optimal adaptation to the recipient site, then it was fixed to the residual ridge with two 1.5mm self-tapping titanium screws. After attaining graft stability, any sharp edges were smoothed and any gap between the graft and underlying alveolar bone was filled with particulate bone curetted from the donner site. Finally, the flap was relaxed by periosteal incisions and blunt muscle dissection from the anterior maxilla or mandible to obtain a primary tension free closure using 4/0 vicryl interrupted and horizontal mattress sutures.
Postsurgical instructions:
Patients were instructed to avoid any wound trauma, and apply ice packs on the host and recipient surgical sites 20min/ hour for the first day after surgery. Proper oral hygiene should be maintained by mouth rinsing with chlorhexidine mouth wash 3times/ day for 1 week. Diclofenac potassium 50mg (Cataflam, Novartis, Switzerland) anti-inflammatory analgesic was prescribed as needed. Clindamycin 300mg twice daily was prescribed for 7days.
Implant insertion:
After 6months, the surgical site was opened to remove fixation screws and insert dental implants, and the final restoration was done 4months after implant insertion.
Evaluation: the patients were scheduled at 3days, 14days, 3months, and 6months postoperatively to evaluate:
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible.
| Arm | Type | Receives |
|---|---|---|
| harvesting and augmentation of bone block | Other | Procedure: harvesting bone block, Procedure: Recipient site preparation, Procedure: implant insertionautogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Missed one or more upper or lower anterior teeth.
- alveolar ridge with horizontal and vertical bone loss (class III according to Seibert et al(1983) classification).
- age 18 to 45 years.
- healthy oral mucosa, at least 3 mm keratinized mucosa.
- no systemic diseases or drugs that affect bone healing.
Key exclusion criteria (5 listed)
- Patients with disturbed occlusion, inadequate inter-arch space.
- patients with parafunction habits as bruxism or clenching.
- pregnancy.
- smokers.
- poor oral hygiene.
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 |
|---|---|---|
| harvesting bone blockAlso: piezo-surgery block harvestingUnder local anesthesia, a sulcular incision was performed between lower right and left second premolars with an oblique incision distal to each one. After that, a full thickness mucoperiosteal flap was elevated to expose the anterior mandible including the entire symphysis and both mental nerves. By using piezo-surgery unit (Surgic Touch, Woodpecker, China), a rectangular bone block was harvested from the symphysis about 8mm in depth and 2mm wider than the recipient site to allow for contouring. The bone cuts were performed 5mm far from the apices of the anterior teeth, mental foramina, and inferior border of the mandible. Finally, thin curved osteotomes was used to detach the bone blocks. The harvested bone block was trimmed to form L-shape block and kept in normal saline. After hemostasis, the flap was closed with 4/0 vicryl interrupted sutures. | Procedure or surgery | harvesting and augmentation of bone block |
| Recipient site preparationAt the maxillary recipient site, after induction of local anesthesia, a mid-crestal incision that continued in the sulcus for two teeth on either side of the defect with bilateral oblique incisions were performed. After that, the full thickness mucoperiosteal flap was elevated. While for mandibular recipient site, it was the same flap used for harvesting symphyseal bone block. For both upper or lower recipient sites, perforations (bone marrow penetration) were done to the recipient site by using a fissure surgical bur. The L-shape block graft was trimmed to obtain optimal adaptation to the recipient site, then it was fixed to the residual ridge with two 1.5mm self-tapping titanium screws. After attaining graft stability, any sharp edges were smoothed and any gap between the graft and underlying alveolar bone was filled with particulate bone curetted from the donner site. | Procedure or surgery | harvesting and augmentation of bone block |
| implant insertionImplant insertion: After 6months, the surgical site was opened to remove fixation screws and insert dental implants, and the final restoration was done 4months after implant insertion. | Procedure or surgery | harvesting and augmentation of bone block |
Primary outcome
numerical rating scale for pain measurement
Time frame: 3 days post-surgery
Pain intensity was measured at three days after surgery on a 0 to 10 numerical rating scale in which 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = the worst pain imaginable.
infection and dehiscence of soft tissue
Time frame: with in 6 months
This was determined clinically by presence=1 or absence=0, of pus formation or graftb exposure.
questionnaire for sensory disturbance
Time frame: with in 6 months
This was assessed by patients' complaint (patient questionnaire) to determine any change in subjective sensation in the lower lip, chin and mental area. if there is pain or not. if there is numbness or not.
width of the alveolar ridge
Time frame: immediate post-operative and after 6 months
CBCT cross section view was used for evaluation of alveolar ridge width and preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.
height of the alveolar ridge
Time frame: immediate post-operative and after 6 months
CBCT cross section view was used for evaluation of alveolar height preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.
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 6 May 2023.
- Individual participant dataSharing planned: No
Related trials for Atrophic Anterior Alveolar Ridge
Recruiting
Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement
Atrophy of Edentulous Maxillary Alveolar Ridge, Alveolar Bone Atrophy
Active, not recruiting
Assessment of Customized 3D Zirconium Versus Titanium Mesh for Anterior Maxillary Ridge Augmentation With Delayed Implant Placement
Ridge Augmentaton and Dental Implants, Bone Loss, Alveolar
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing harvesting bone block, Recipient site preparation and implant insertion in people with Atrophic Anterior Alveolar Ridge, run by Mansoura 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 5 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 6 May 2023. 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?
numerical rating scale for pain measurement (time frame: 3 days post-surgery). The study lists 5 primary outcomes in all. 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 6 May 2023.