Tooth ExtractionNCT04957654
Vestibular Socket Therapy in Immediate Implants With Grafting Materials
A study testing VST with collagen plug soaked in blood, VST with Allograft Demineralized bone matrix Grafton and VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles in people with Tooth Extraction and Dental Implant, run by Mohamed Mofreh Hamada Hamed at 1 site in Egypt.
Trial summary
The current research aims at evaluating the outcomes of the vestibular socket therapy in immediate implants using collagen plug, demineralized freeze-dried bone allograft, and deproteinized bovine bone minerals at both radiographic and clinical levels Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Tooth Extraction, Dental Implant, Extarction Socket
- What is being tested?
- VST with collagen plug soaked in blood, VST with Allograft Demineralized bone matrix Grafton and VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Mar 2021to 1 Jul 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be included if they have one or more hopeless teeth without signs of acute infection in the maxillary anterior region.
- Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
- Medically free
Who cannot join
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Smokers, diabetics, pregnant or lactating women.
- History of chemotherapy, radiotherapy in head and/or neck region.
- Bisphosphonate therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Tanta University
Tanta
Mohamed M Hamed, BDS, 01023888701 ext. 002, mohamedhamed628@gmail.com
Mohamed M Hamed, BDS
About this study
Official title: A Comparative Study Evaluating Vestibular Socket Therapy in Immediate Implants Using Different Grafting Materials
The current research aims at evaluating the outcomes of the vestibular socket therapy in immediate implants using collagen plug, demineralized freeze-dried bone allograft, and deproteinized bovine bone minerals at both radiographic and clinical levels
- Conditions
- Tooth Extraction, Dental Implant, Extarction Socket
- Being tested
- VST with collagen plug soaked in blood, VST with Allograft Demineralized bone matrix Grafton, VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VST with collagen plug soaked in bloodOther
-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with collagen plug soaked in blood
VST with Allograft Demineralized bone matrix GraftonOther
-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with Allograft Demineralized bone matrix Grafton
VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particlesOther
-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles
| Study group | Role | What they receive |
|---|---|---|
| VST with collagen plug soaked in blood | Experimental | Not described Receives: Other: VST with collagen plug soaked in blood |
| VST with Allograft Demineralized bone matrix Grafton | Active comparator | Not described Receives: Other: VST with Allograft Demineralized bone matrix Grafton |
| VST with autogenous cortical chips and bovine deprotinzed particles | Active comparator | Not described Receives: Other: VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in facial plate thickness
Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess the thickness of the labial (facial) plate of bone and implant survival
Measured: at baseline, 6 and 12 months
changes in facial plate height
Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess height of labial (facial) plate of bone and implant survival
Measured: at baseline, 6 and 12 months
Secondary outcomes (1)
changes in peri-implant mucosal level
Each group will be subjected to Intraoral scanning at baseline, 6 months and 12 months. The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.
Measured: at baseline, 3rd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start16 Mar 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion1 Jul 2022 (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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Mofreh Hamada Hamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Mofreh Hamada Hamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957654
- Sponsor's protocol ID
- 04-21-13
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hamed MM, El-Tonsy MM, Elaskary A, Abdelaziz GO, Saeed SS, Elfahl BN. Effect of three different grafting materials on immediate implant placement using vestibular socket therapy in class II extraction sockets in the maxillary esthetic zone: a randomized controlled clinical trial. BMC Oral Health. 2023 Sep 1;23(1):623. doi: 10.1186/s12903-023-03345-9.
PubMed 37658342
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Evaluating Vestibular Socket Therapy in Immediate Implants Using Different Grafting Materials
- ClinicalTrials.gov ID
- NCT04957654
- Acronym / sponsor ID
- 04-21-13
- Conditions
- Tooth Extraction, Dental Implant, Extarction Socket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mohamed Mofreh Hamada HamedUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 12 Jul 2021 (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 current research aims at evaluating the outcomes of the vestibular socket therapy in immediate implants using collagen plug, demineralized freeze-dried bone allograft, and deproteinized bovine bone minerals at both radiographic and clinical levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VST with collagen plug soaked in blood | Experimental | Other: VST with collagen plug soaked in blood |
| VST with Allograft Demineralized bone matrix Grafton | Active comparator | Other: VST with Allograft Demineralized bone matrix Grafton |
| VST with autogenous cortical chips and bovine deprotinzed particles | Active comparator | Other: VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients will be included if they have one or more hopeless teeth without signs of acute infection in the maxillary anterior region.
- Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
- Medically free
Key exclusion criteria (4 listed)
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Smokers, diabetics, pregnant or lactating women.
- History of chemotherapy, radiotherapy in head and/or neck region.
- Bisphosphonate therapy
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 |
|---|---|---|
| VST with collagen plug soaked in blood-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with collagen plug soaked in blood | Other | VST with collagen plug soaked in blood |
| VST with Allograft Demineralized bone matrix Grafton-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with Allograft Demineralized bone matrix Grafton | Other | VST with Allograft Demineralized bone matrix Grafton |
| VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles | Other | VST with autogenous cortical chips and bovine deprotinzed particles |
Primary outcome
changes in facial plate thickness
Time frame: at baseline, 6 and 12 months
Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess the thickness of the labial (facial) plate of bone and implant survival
changes in facial plate height
Time frame: at baseline, 6 and 12 months
Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess height of labial (facial) plate of bone and implant survival
1 secondary outcome
changes in peri-implant mucosal level
Time frame: at baseline, 3rd and 6th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Derived from this study: PubMed 37658342Hamed MM, El-Tonsy MM, Elaskary A, Abdelaziz GO, Saeed SS, Elfahl BN. Effect of three different grafting materials on immediate implant placement using vestibular socket therapy in class II extraction sockets in the maxillary esthetic zone: a randomized controlled clinical trial. BMC Oral Health. 2023 Sep 1;23(1):623. doi: 10.1186/s12903-023-03345-9.
Related trials for Tooth Extraction
Recruiting
Comparing Cross-Linked and Non-Cross-Linked Hyaluronic Acid for Early Healing After Tooth Extraction
Wound Healing After Tooth Extraction
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
RecruitingObservational study
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Stomatognatic, Tooth Diseases
Not yet recruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VST with collagen plug soaked in blood, VST with Allograft Demineralized bone matrix Grafton and VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles in people with Tooth Extraction and Dental Implant, run by Mohamed Mofreh Hamada Hamed 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 4 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 12 Jul 2021. 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 Mohamed M Hamed, BDS (01023888701 ext. 002, mohamedhamed628@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in facial plate thickness (time frame: at baseline, 6 and 12 months). The study lists 2 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 NCT04957654, 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 12 Jul 2021.