Mandible CystNCT05987930
Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions
A study testing bone lid technique and standard technique in people with Mandible Cyst and Mandible Tumor, run by Tanta University at 1 site in Egypt.
Trial summary
Twenty patients with benign mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mandible Cyst, Mandible Tumor, Mandibular Diseases
- What is being tested?
- bone lid technique and standard technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2023to 20 Dec 2023
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age ≥ 6 years
- presence of bony lesion (cysts, benign tumors, odontoma) located in mandibular region,
- the existence of a normal residual buccal cortical plate with the adequate thickness (≥1 mm) at least at the periphery of buccal cortical plate
Who cannot join
- • patients taking medications that affect bone metabolism,
- patients underwent head and neck radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer of Oral and Maxillofacial Surgery
Twenty patients with benign mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
The patients will be evaluated clinically to evaluate healing and radiographically using cone beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six months later
Read the detailed description
Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid technique performed using a piezoelectric device versus the traditional technique in patients requiring excision of the mandibular bony lesions
Materials \& Methods: Twenty patients with mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.
Surgical procedure: A full thickness flap will be elevated in both groups to achieve access to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond the actual extension of lesion in radiograph using piezoelectric device to secure a latter repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in saline. After excision of the lesion, the bony lid will be repositioned to its original position and fixed to the bone with an absorbable suture.
In group II the bone will be removed buccally using surgical bur then the lesion is removed. Finally, the flap will be sutured in both groups.
Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of infection, inflammation, necrosis, or bone exposure each week for one month then monthly for six months.
Radiographically, (CBCT) scan six months later to evaluate Healing and integration of the repositioned bone lid, any signs of recurrence in the case of cysts, and filling of the bone defect bone healing and volume of the defect.
All selected cases of both groups b were went for CBCT scan using fixed exposure parameters (Kv, mA) and the same field of view prior surgery and 6 months post-surgical using the same axial slicing to evaluate the following
- Cyst area in coronal view for posterior region and sagittal view for anterior region
- Evaluating lesion location by making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion using (Coronal view posterior, sagittal anterior).
3- recurrence of lesion , integration of buccal cortex 4- bone density
- Conditions
- Mandible Cyst, Mandible Tumor, Mandibular Diseases
- Being tested
- bone lid technique, standard technique
- Keywords
- mandibular lesions, bone lid technique, standard technique
- Medical subject headings
- Mandibular Neoplasms, Mandibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone lid techniqueDevice
group I ten patients with mandibular lesion will be undergo excision of lesion using bone lid technique with piezo-electric device then reposition of buccal bone cortex
standard techniqueDevice
group II ten patients with mandibular lesion will be undergo excision of lesion using surgical bur to remove buccal cortex to get access to lesion
| Study group | Role | What they receive |
|---|---|---|
| bone lid technique | Experimental | ten patients with mandibular benign lesions which were treated with bone lid technique to enucleate the lesion using piezo-electric device to allow removal of buccal bone cortex with preservation of it to have access to lesion then reposition of bone lid in its place Receives: Device: bone lid technique |
| standard technique | Experimental | ten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion Receives: Device: standard technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of pain evaluated clinically in both groups
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
Measured: one-two weeks
soft tissue healing evaluated clinically in both groups
adequate means closed or inadequate means open wound
Measured: one week
infection evaluated clinically in both groups
1 means mild,2 means moderate or3 means sever infection
Measured: one week-one month
cyst area calculation radiographically in both groups
using CBCT to measure the area in mm2
Measured: six months
measuring the distance between the lesion and alveolar crest in both groups
making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.
Measured: six months
density of bone calculated radiographically in both groups
CBCT to measure density (D1> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield
Measured: six months
Secondary outcomes (2)
inflammation clinically in both groups
0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
Measured: one week
integration of buccal cortex radigraphically in both groups
presence of radiolucency around of buccal cortex or not
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Jun 2023
- Primary completion30 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandible CystStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona samy sheta, Tanta University
- Investigators
- mona s sheta, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987930
- Sponsor's protocol ID
- 1611
- Status last verified
- Jan 2024
- First submitted
- 11 Jul 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheta MS, Ghouraba RF, Ibrahim MT. Bone lid technique versus standard technique for treatment of mandibular lesions. BMC Oral Health. 2024 Aug 2;24(1):875. doi: 10.1186/s12903-024-04594-y.
PubMed 39095818
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Oral and Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT05987930
- Acronym / sponsor ID
- 1611
- Conditions
- Mandible Cyst, Mandible Tumor, Mandibular Diseases
- Keywords
- mandibular lesions, bone lid technique, standard technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 14 Aug 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.
Twenty patients with benign mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
The patients will be evaluated clinically to evaluate healing and radiographically using cone beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six months later
Detailed description
Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid technique performed using a piezoelectric device versus the traditional technique in patients requiring excision of the mandibular bony lesions
Materials \& Methods: Twenty patients with mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.
Surgical procedure: A full thickness flap will be elevated in both groups to achieve access to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond the actual extension of lesion in radiograph using piezoelectric device to secure a latter repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in saline. After excision of the lesion, the bony lid will be repositioned to its original position and fixed to the bone with an absorbable suture.
In group II the bone will be removed buccally using surgical bur then the lesion is removed. Finally, the flap will be sutured in both groups.
Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of infection, inflammation, necrosis, or bone exposure each week for one month then monthly for six months.
Radiographically, (CBCT) scan six months later to evaluate Healing and integration of the repositioned bone lid, any signs of recurrence in the case of cysts, and filling of the bone defect bone healing and volume of the defect.
All selected cases of both groups b were went for CBCT scan using fixed exposure parameters (Kv, mA) and the same field of view prior surgery and 6 months post-surgical using the same axial slicing to evaluate the following
- Cyst area in coronal view for posterior region and sagittal view for anterior region
- Evaluating lesion location by making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion using (Coronal view posterior, sagittal anterior).
3- recurrence of lesion , integration of buccal cortex 4- bone density
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bone lid technique | Experimental | Device: bone lid techniqueten patients with mandibular benign lesions which were treated with bone lid technique to enucleate the lesion using piezo-electric device to allow removal of buccal bone cortex with preservation of it to have access to lesion then reposition of bone lid in its place |
| standard technique | Experimental | Device: standard techniqueten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 6 years
- presence of bony lesion (cysts, benign tumors, odontoma) located in mandibular region,
- the existence of a normal residual buccal cortical plate with the adequate thickness (≥1 mm) at least at the periphery of buccal cortical plate
Key exclusion criteria (2 listed)
- • patients taking medications that affect bone metabolism,
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 |
|---|---|---|
| bone lid techniquegroup I ten patients with mandibular lesion will be undergo excision of lesion using bone lid technique with piezo-electric device then reposition of buccal bone cortex | Device | bone lid technique |
| standard techniquegroup II ten patients with mandibular lesion will be undergo excision of lesion using surgical bur to remove buccal cortex to get access to lesion | Device | standard technique |
Primary outcome
degree of pain evaluated clinically in both groups
Time frame: one-two weeks
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing evaluated clinically in both groups
Time frame: one week
adequate means closed or inadequate means open wound
infection evaluated clinically in both groups
Time frame: one week-one month
1 means mild,2 means moderate or3 means sever infection
cyst area calculation radiographically in both groups
Time frame: six months
using CBCT to measure the area in mm2
measuring the distance between the lesion and alveolar crest in both groups
Time frame: six months
making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.
density of bone calculated radiographically in both groups
Time frame: six months
CBCT to measure density (D1> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield
2 secondary outcomes
inflammation clinically in both groups
Time frame: one week
integration of buccal cortex radigraphically in both groups
Time frame: six months
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 11 Jan 2024.
- Derived from this study: PubMed 39095818Sheta MS, Ghouraba RF, Ibrahim MT. Bone lid technique versus standard technique for treatment of mandibular lesions. BMC Oral Health. 2024 Aug 2;24(1):875. doi: 10.1186/s12903-024-04594-y.
Related trials for Mandible Cyst
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
Recruiting
Artificial Intelligence-Based Assessment of Endosseous Lesions
Maxillary Cyst, Mandibular Cyst
Recruiting
Treatment of Mandibular Bone Cyst by Navigation and Endoscopy
Jaw Cysts
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.
mona s sheta principal investigator
Tanta 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 bone lid technique and standard technique in people with Mandible Cyst and Mandible Tumor, run by Tanta 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 3 inclusion and 2 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 11 Jan 2024. 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?
degree of pain evaluated clinically in both groups (time frame: one-two weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987930, which also lists 1 linked publication.
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 11 Jan 2024.