Bone Resorption After Tooth ExtractionNCT03065803
Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.
A study testing Buccal plate expansion technique for dental socket preservation and Guided bone regeneration technique for post-extraction dental socket preservation in people with Bone Resorption After Tooth Extraction, run by Passant Khaled Tayaa.
Trial summary
Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption After Tooth Extraction
- What is being tested?
- Buccal plate expansion technique for dental socket preservation and Guided bone regeneration technique for post-extraction dental socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 1 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar.
- Cause of tooth extraction is due to caries, trauma or failed endodontic treatment.
- Only teeth with intact buccal bone plate will be considered for this study.
- Patients who are cooperative, motivated and hygiene conscious.
- Patients whose age is >18 years
Who cannot join
- Systemic conditions/disease that contraindicated surgery.
- Patients on drugs that may compromise bone healing.
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Smokers.
- Patients with Psychologic disorder.
- Pregnancy or lactation.
- Presence of acute periodontal or periapical pathology.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Assessment of Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in The Esthetic Zone: A Randomized Controlled Clinical Trial
Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.
- Conditions
- Bone Resorption After Tooth Extraction
- Being tested
- Buccal plate expansion technique for dental socket preservation, Guided bone regeneration technique for post-extraction dental socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal plate expansion technique for dental socket preservationProcedure or surgery
Also called Internal corticotomy for buccal plate of bone in extraction socket for socket preservation
An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar).
Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0).
Guided bone regeneration technique for post-extraction dental socket preservationProcedure or surgery
After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed.The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone.. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0)
| Study group | Role | What they receive |
|---|---|---|
| Buccal plate expansion technique in dental socket preservation | Active comparator | An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar).
Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0). Receives: Procedure: Buccal plate expansion technique for dental socket preservation |
| Guided Bone regeneration technique for socket preservation | Other | On buccal side, two vertical incisions will be made at mesial and distal papilla of the adjoining teeth. These incisions will be stretched out past mucogingival junction. After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed. The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0) (Sadeghi et al., 2016). Receives: Procedure: Guided bone regeneration technique for post-extraction dental socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
measuring the horizontal and vertical bone loss after socket preservation using cone beam computed tomography (CBCT).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Resorption After Tooth ExtractionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Passant Khaled Tayaa
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Passant Khaled Tayaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065803
- Sponsor's protocol ID
- Dental socket preservation
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be available for other scientists after the end of the study on www.clinicaltrials.gov , all data will be shared except patient contact or private data
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in The Esthetic Zone: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03065803
- Acronym / sponsor ID
- Dental socket preservation
- Conditions
- Bone Resorption After Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Passant Khaled TayaaUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 28 Feb 2017 (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.
Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal plate expansion technique in dental socket preservation | Active comparator | Procedure: Buccal plate expansion technique for dental socket preservationAn internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0). |
| Guided Bone regeneration technique for socket preservation | Other | Procedure: Guided bone regeneration technique for post-extraction dental socket preservationOn buccal side, two vertical incisions will be made at mesial and distal papilla of the adjoining teeth. These incisions will be stretched out past mucogingival junction. After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed. The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0) (Sadeghi et al., 2016). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar.
- Cause of tooth extraction is due to caries, trauma or failed endodontic treatment.
- Only teeth with intact buccal bone plate will be considered for this study.
- Patients who are cooperative, motivated and hygiene conscious.
- Patients whose age is >18 years
Key exclusion criteria (7 listed)
- Systemic conditions/disease that contraindicated surgery.
- Patients on drugs that may compromise bone healing.
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Smokers.
- Patients with Psychologic disorder.
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 |
|---|---|---|
| Buccal plate expansion technique for dental socket preservationAlso: Internal corticotomy for buccal plate of bone in extraction socket for socket preservationAn internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0). | Procedure or surgery | Buccal plate expansion technique in dental socket preservation |
| Guided bone regeneration technique for post-extraction dental socket preservationAfter full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed.The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone.. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0) | Procedure or surgery | Guided Bone regeneration technique for socket preservation |
Primary outcome
measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
Time frame: 4 months
measuring the horizontal and vertical bone loss after socket preservation using cone beam computed tomography (CBCT).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Yes. the data will be available for other scientists after the end of the study on www.clinicaltrials.gov , all data will be shared except patient contact or private data
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal plate expansion technique for dental socket preservation and Guided bone regeneration technique for post-extraction dental socket preservation in people with Bone Resorption After Tooth Extraction, run by Passant Khaled Tayaa.
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 28 Feb 2017. 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 Passant Khaled (20201005533777, dr.passant.khaled@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring horizontal and vertical bone dimensions 4 months after the surgical intervention. (time frame: 4 months). 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 28 Feb 2017.