Alveolar Socket PreservationPhase 4NCT03690973
Evaluation of Bone Changes After Immediate Implant Placement or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone
A Phase 4 study testing Alveolar socket preservation with graft and flap surgery, Immediate implant placement with bone using flapless surgery and Immediate implant placement with bone using flap surgery in people with Alveolar Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
The amount of hard tissue resorption following tooth extraction involves prosthetically driven implant placement; therefore, the development of ridge preservation techniques that result in less alveolar bone loss is of great interest, Alveolar ridge preservation are indicated to decrease the loss of ridge volume that… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Socket Preservation
- What is being tested?
- Alveolar socket preservation with graft and flap surgery, Immediate implant placement with bone using flapless surgery and Immediate implant placement with bone using flap surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2018to 30 Mar 2021
- Phase
- Phase 4
- 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
- Age: Above 18 years.
- Patients with single non-restorable teeth in anterior or premolar area.
- Patients with adequate bone volume for the dental implant procedure.
- Patients with good oral hygiene
- Patient consent approval and signing.
Who cannot join
- Heavy smokers.
- Systemic disease that contraindicates surgical implant placement
- Presence of any acute pathosis at the site of surgery.
- Patients with thin alveolar ridge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bone Changes of The Extraction Sockets After Immediate Implant or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone "Randomized Controlled Clinical Trial"
The amount of hard tissue resorption following tooth extraction involves prosthetically driven implant placement; therefore, the development of ridge preservation techniques that result in less alveolar bone loss is of great interest, Alveolar ridge preservation are indicated to decrease the loss of ridge volume that follows tooth extraction.However, they do not prevent bone resorption because, depending on the technique.The protocol of placing implants immediately upon tooth extraction has been introduced into clinical practice which aims to preserve the socket from resorption, also immediate implant satisfy the patient as it decrease the time for crown insertion in addition to that it has a good survival.There is not adequate research data to clearly demonstrate that flapless socket preservation techniques are superior to techniques that involve raising a flap, but an animal study reported that the detachment of the periosteum from the buccal site of the ridge leads to an increase of the resorption rate, resulting in an increase of the ridge resorption
Read the detailed description
Socket preservation procedures have been performed to preserve hard and soft tissue volume, which can be partially lost after tooth removal. These procedures allow for wider and longer implant placement compared with non-augmented sockets and reduce the need for simultaneous augmentation procedures at the time of implant placement.It is expected that immediate implant avoid crestal resorption in the fresh extraction socket in humans also immediate installation at the time of extraction offers potential advantages for both practitioners and patients. It allows a decrease in treatment time and may result in an increase in patient satisfaction.Also it is expected that flapless procedure include maintenance of the buccal keratinized gingival , and prevention of alterations to the gingival contours and migration of the mucogingival junction that are often experienced after raising a flap
- Conditions
- Alveolar Socket Preservation
- Being tested
- Alveolar socket preservation with graft and flap surgery, Immediate implant placement with bone using flapless surgery, Immediate implant placement with bone using flap surgery, Alveolar socket preservation with graft and flapless surgery
- Keywords
- Bone graft, Immediate dental implant, Flap, Flapless
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar socket preservation with graft and flap surgeryDrug
Alveolar socket preservation with xenogenic bone graft and flap surgery
Immediate implant placement with bone using flapless surgeryDevice
Immediate implant placement with xenogenic bone graft using flapless surgery
Immediate implant placement with bone using flap surgeryDevice
Immediate implant placement with xenogenic bone graft using flap surgery
Alveolar socket preservation with graft and flapless surgeryDrug
Alveolar socket preservation with xenogenic bone graft and flapless surgery
| Study group | Role | What they receive |
|---|---|---|
| Alveolar socket preservation with graft and flap surgery | Active comparator | Not described Receives: Drug: Alveolar socket preservation with graft and flap surgery |
| Immediate implant placement with bone using flapless surgery | Experimental | Not described Receives: Device: Immediate implant placement with bone using flapless surgery |
| Immediate implant placement with bone and flap surgery | Experimental | Not described Receives: Device: Immediate implant placement with bone using flap surgery |
| Alveolar socket preservation with graft and flapless surgery | Experimental | Not described Receives: Drug: Alveolar socket preservation with graft and flapless surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume changes
volumetric bone changes by cone-beam computed tomography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start30 Sep 2018
- Primary completion30 Dec 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Socket PreservationStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Shaarawi, Cairo University
- Investigators
- Amr Zahran, Phd, Study chair, Cairo UniversityAhmed Reda, Phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690973
- Sponsor's protocol ID
- perio2018
- Status last verified
- Jul 2021
- First submitted
- 28 Sep 2018
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: I will check with my study chair
Publications
Aimetti M, Manavella V, Corano L, Ercoli E, Bignardi C, Romano F. Three-dimensional analysis of bone remodeling following ridge augmentation of compromised extraction sockets in periodontitis patients: A randomized controlled study. Clin Oral Implants Res. 2018 Feb;29(2):202-214. doi: 10.1111/clr.13099. Epub 2017 Nov 17.
PubMed 29148597Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.
PubMed 27978602
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Changes of The Extraction Sockets After Immediate Implant or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone "Randomized Controlled Clinical Trial"
- ClinicalTrials.gov ID
- NCT03690973
- Acronym / sponsor ID
- perio2018
- Conditions
- Alveolar Socket Preservation
- Keywords
- Bone graft, Immediate dental implant, Flap, Flapless
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 1 Oct 2018 (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 amount of hard tissue resorption following tooth extraction involves prosthetically driven implant placement; therefore, the development of ridge preservation techniques that result in less alveolar bone loss is of great interest, Alveolar ridge preservation are indicated to decrease the loss of ridge volume that follows tooth extraction.However, they do not prevent bone resorption because, depending on the technique.The protocol of placing implants immediately upon tooth extraction has been introduced into clinical practice which aims to preserve the socket from resorption, also immediate implant satisfy the patient as it decrease the time for crown insertion in addition to that it has a good survival.There is not adequate research data to clearly demonstrate that flapless socket preservation techniques are superior to techniques that involve raising a flap, but an animal study reported that the detachment of the periosteum from the buccal site of the ridge leads to an increase of the resorption rate, resulting in an increase of the ridge resorption
Detailed description
Socket preservation procedures have been performed to preserve hard and soft tissue volume, which can be partially lost after tooth removal. These procedures allow for wider and longer implant placement compared with non-augmented sockets and reduce the need for simultaneous augmentation procedures at the time of implant placement.It is expected that immediate implant avoid crestal resorption in the fresh extraction socket in humans also immediate installation at the time of extraction offers potential advantages for both practitioners and patients. It allows a decrease in treatment time and may result in an increase in patient satisfaction.Also it is expected that flapless procedure include maintenance of the buccal keratinized gingival , and prevention of alterations to the gingival contours and migration of the mucogingival junction that are often experienced after raising a flap
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Alveolar socket preservation with graft and flap surgery | Active comparator | Drug: Alveolar socket preservation with graft and flap surgery |
| Immediate implant placement with bone using flapless surgery | Experimental | Device: Immediate implant placement with bone using flapless surgery |
| Immediate implant placement with bone and flap surgery | Experimental | Device: Immediate implant placement with bone using flap surgery |
| Alveolar socket preservation with graft and flapless surgery | Experimental | Drug: Alveolar socket preservation with graft and flapless surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Above 18 years.
- Patients with single non-restorable teeth in anterior or premolar area.
- Patients with adequate bone volume for the dental implant procedure.
- Patients with good oral hygiene
- Patient consent approval and signing.
Key exclusion criteria (4 listed)
- Heavy smokers.
- Systemic disease that contraindicates surgical implant placement
- Presence of any acute pathosis at the site of surgery.
- Patients with thin alveolar ridge.
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 |
|---|---|---|
| Alveolar socket preservation with graft and flap surgeryAlveolar socket preservation with xenogenic bone graft and flap surgery | Drug | Alveolar socket preservation with graft and flap surgery |
| Immediate implant placement with bone using flapless surgeryImmediate implant placement with xenogenic bone graft using flapless surgery | Device | Immediate implant placement with bone using flapless surgery |
| Immediate implant placement with bone using flap surgeryImmediate implant placement with xenogenic bone graft using flap surgery | Device | Immediate implant placement with bone and flap surgery |
| Alveolar socket preservation with graft and flapless surgeryAlveolar socket preservation with xenogenic bone graft and flapless surgery | Drug | Alveolar socket preservation with graft and flapless surgery |
Primary outcome
Bone volume changes
Time frame: 1 year
volumetric bone changes by cone-beam computed tomography
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 5 Aug 2021.
- Background: PubMed 29148597Aimetti M, Manavella V, Corano L, Ercoli E, Bignardi C, Romano F. Three-dimensional analysis of bone remodeling following ridge augmentation of compromised extraction sockets in periodontitis patients: A randomized controlled study. Clin Oral Implants Res. 2018 Feb;29(2):202-214. doi: 10.1111/clr.13099. Epub 2017 Nov 17.
- Background: PubMed 27978602Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.
- Individual participant dataSharing planned: No. I will check with my study chair
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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.
Amr Zahran, Phd study chair
Cairo University
Ahmed Reda, Phd study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alveolar socket preservation with graft and flap surgery, Immediate implant placement with bone using flapless surgery and Immediate implant placement with bone using flap surgery in people with Alveolar Socket Preservation, run by Cairo 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 5 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: finished, as of the sponsor's last update on 5 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone volume changes (time frame: 1 year). 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 NCT03690973, which also lists 2 linked publications.
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 5 Aug 2021.