Dental ImplantNCT04415619
Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement
A study testing Xenograft bone substitute (Osteo-biol) in people with Dental Implant, run by Alexandria University.
Trial summary
Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Xenograft bone substitute (Osteo-biol)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 20 Nov 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age between 20-45 years with no gender predilection.
- Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
- Patients with good oral hygiene.
- Bony defects more than 2 mm during implant placement treated by bone substitute.
- Patients fully capable to comply with the study protocol.
Who cannot join
- Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
- Heavy smokers (more than 20 cigarettes per day).
- Sites with acute oral infection.
- Pregnant and lactating patients.
- Untreated periodontal disease.
- Previous chemotherapy or irradiation of the head and neck.
- Inadequate interocclusal space.
Trial locations and contacts
No sites are listed yet.
Lobna Elwan, BSc contact
About this study
Official title: Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area
Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.
Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.
Read the detailed description
Ten patients will be selected randomly from the outpatient clinic, Alexandria University seeking for an immediate implant placement. The sample will be selected to match the inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth extraction, placement of an immediate implant, bone grafting material and autologous soft tissue graft from the buccal pad of fat. Patients will be assessed clinically and radiographically to evaluate bone and soft tissue measurements.
- Conditions
- Dental Implant
- Being tested
- Xenograft bone substitute (Osteo-biol)
- Keywords
- Implant, Buccal fat pad, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenograft bone substitute (Osteo-biol)Procedure or surgery
Also called Implant(Superline®,DentiumCoTM), Osstell(ISQ®)
Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 10 patients will have immediate implant placement with buccal pad of fat free tissue Receives: Procedure: Xenograft bone substitute (Osteo-biol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using:
a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain).
Measured: 6 months
Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
Measured: 6 months
Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Evaluation of soft tissue healing
At week 1, week4 and at 6 months:
Presence/absence of postoperative complications will be evaluated, including:
Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation.
Measured: 6 months
Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
Measured: 6 months
Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
After 3 months then at 6 months Cone Beam CT will be requested in order to measure:
- Bone density.
- Amount of bone buccally and palatally to the implant.
- Marginal bone loss.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion13 Oct 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
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 Dental ImplantStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Not applicable
- Intervention model
- Single group
- Model description
- A group of 10 patients will receive immediate implant placement with buccal pad of fat coverage
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Youssef Attia, Alexandria University
- Investigators
- Lobna Elwan, BSc, Principal investigator, Alexandria UniversityNagy El Prince, PhD, Study director, Alexandria UniversityAhmed O. Swedan, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415619
- Sponsor's protocol ID
- Buccal pad of fat free tissue
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Penarrocha-Diago M, Alonso-Gonzalez R, Aloy-Prosper A, Penarrocha-Oltra D, Camacho F, Penarrocha-Diago M. Use of buccal fat pad to repair post-extraction peri-implant bone defects in the posterior maxilla. A preliminary prospective study. Med Oral Patol Oral Cir Bucal. 2015 Nov 1;20(6):e699-706. doi: 10.4317/medoral.20212.
PubMed 26241450
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area
- ClinicalTrials.gov ID
- NCT04415619
- Acronym / sponsor ID
- Buccal pad of fat free tissue
- Conditions
- Dental Implant
- Keywords
- Implant, Buccal fat pad, Immediate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 13 Oct 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 4 Jun 2020 (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.
Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.
Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.
Detailed description
Ten patients will be selected randomly from the outpatient clinic, Alexandria University seeking for an immediate implant placement. The sample will be selected to match the inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth extraction, placement of an immediate implant, bone grafting material and autologous soft tissue graft from the buccal pad of fat. Patients will be assessed clinically and radiographically to evaluate bone and soft tissue measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A group of 10 patients will receive immediate implant placement with buccal pad of fat coverage
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Xenograft bone substitute (Osteo-biol)10 patients will have immediate implant placement with buccal pad of fat free tissue |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients age between 20-45 years with no gender predilection.
- Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
- Patients with good oral hygiene.
- Bony defects more than 2 mm during implant placement treated by bone substitute.
- Patients fully capable to comply with the study protocol.
Key exclusion criteria (7 listed)
- Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
- Heavy smokers (more than 20 cigarettes per day).
- Sites with acute oral infection.
- Pregnant and lactating patients.
- Untreated periodontal disease.
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 |
|---|---|---|
| Xenograft bone substitute (Osteo-biol)Also: Implant(Superline®,DentiumCoTM), Osstell(ISQ®)Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction. | Procedure or surgery | Intervention group |
Primary outcome
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Time frame: 6 months
Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using: a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain).
Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Time frame: 6 months
Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Time frame: 6 months
Evaluation of soft tissue healing At week 1, week4 and at 6 months: Presence/absence of postoperative complications will be evaluated, including: Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation.
Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
Time frame: 6 months
Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Time frame: 6 months
After 3 months then at 6 months Cone Beam CT will be requested in order to measure: * Bone density. * Amount of bone buccally and palatally to the implant. * Marginal bone loss.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 26241450Penarrocha-Diago M, Alonso-Gonzalez R, Aloy-Prosper A, Penarrocha-Oltra D, Camacho F, Penarrocha-Diago M. Use of buccal fat pad to repair post-extraction peri-implant bone defects in the posterior maxilla. A preliminary prospective study. Med Oral Patol Oral Cir Bucal. 2015 Nov 1;20(6):e699-706. doi: 10.4317/medoral.20212.
- Individual participant dataSharing planned: Undecided
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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.
Lobna Elwan, BSc contact
Lobna Elwan, BSc principal investigator
Alexandria University
Nagy El Prince, PhD study director
Alexandria University
Ahmed O. Swedan, PhD study director
Alexandria University
Questions about this trial
What is this clinical trial studying?
A study testing Xenograft bone substitute (Osteo-biol) in people with Dental Implant, run by Alexandria University.
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 7 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Dina Y. Attia, MSc (+01017510444, dina.youssef29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area. (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT04415619, 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 4 Jun 2020.