Buccal Bone Loss in Immediate ImplantsNCT03007316
Evaluation of Esthetics Around Immediate Implants in VIP - CT Grafted vs Non-grafted Sites.RCT
A study testing VIP graft in people with Buccal Bone Loss in Immediate Implants, run by Cairo University at 1 site in Egypt.
Trial summary
An array of soft tissue augmentation techniques have been employed concomitant to implant placement, as free connective tissue grafts or pedicle grafts for keratinized tissue thickening in attempt not only to augment the soft tissue for better resistance to inflammation and improved esthetic stability, but to preserve… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Buccal Bone Loss in Immediate Implants
- What is being tested?
- VIP graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2017to 12 Mar 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
- Patients with healthy systemic condition.
- Buccal bone thickness should be at least 1mm.
- Availability of bone apical and palatal to the socket to provide primary stability.
- Good oral hygiene.
Who cannot join
- Patients with signs of acute infection related to the area of interest.
- Current and former smokers
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implants in Vascularized Interpositional Periosteal Connective Tissue Grafted Versus Non-grafted Sites. A Randomized Controlled Clinical Trial.
An array of soft tissue augmentation techniques have been employed concomitant to implant placement, as free connective tissue grafts or pedicle grafts for keratinized tissue thickening in attempt not only to augment the soft tissue for better resistance to inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.
Results obtained from the literature were controversial regarding the need of soft tissue augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature was found, that monitored the ridge alterations following implant placement.
Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and buccal bone resorption during the process of remodeling in a measurable way.
Read the detailed description
Alveolar bone remodeling following extraction could not be prevented by immediate implant placement. Soft tissue augmentaion techniques have been suggested in order to overcome the alterations of buccal bone during remodeling. Nevertheless, it is still inconclusive whether soft tissue augmentation procedures actually have a protective role in preserving buccal bone thickness in immediate implants.
Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal bone resorption and pink esthetics around immediately placed implants in maxillary anterior teeth after 24 months following implant placement. 18 non-restorable maxillary anterior teeth randomly assigned into 2 groups: (test group) immediately placed implants with simultaneous vascular interpositional periosteal connective tissue (VIP-CT) grafting versus non-augmented implant sites (control group). Buccal bone changes were assessed at implant placement (0) and at 4,9,12 and 24 months from baseline by specially manufactured device and at 24 months by cone beam computed tomography scans (CBCT). Pink esthetic score (PES) was evaluated at 6, 9, 12 and 24 months intervals. Pain and satisfaction were assessed through questionnaires to the patients.
- Conditions
- Buccal Bone Loss in Immediate Implants
- Being tested
- VIP graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP graftProcedure or surgery
surgical soft tissue grafting concomitant to implant placement
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implants + VIP graft. | Experimental | Immediate implants placed with simultaneous vascularized interpositional periosteal (VIP) connective tissue graft augmentation. Receives: Procedure: VIP graft |
| Immediate Implants only | No intervention | Immediate Implants only without soft tissue augmentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"PES" Pink Esthetic Score
esthetic assessment by the pink esthetic score introduced by furhauser et al 2005
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion17 Dec 2019
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal Bone Loss in Immediate ImplantsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzy Nabil Naiem, Cairo University
- Investigators
- Hani El Nahass, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007316
- Sponsor's protocol ID
- 0
- Status last verified
- Nov 2020
- First submitted
- 23 Dec 2016
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implants in Vascularized Interpositional Periosteal Connective Tissue Grafted Versus Non-grafted Sites. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03007316
- Acronym / sponsor ID
- 0
- Conditions
- Buccal Bone Loss in Immediate Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 2 Jan 2017 (estimated)
- 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.
An array of soft tissue augmentation techniques have been employed concomitant to implant placement, as free connective tissue grafts or pedicle grafts for keratinized tissue thickening in attempt not only to augment the soft tissue for better resistance to inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.
Results obtained from the literature were controversial regarding the need of soft tissue augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature was found, that monitored the ridge alterations following implant placement.
Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and buccal bone resorption during the process of remodeling in a measurable way.
Detailed description
Alveolar bone remodeling following extraction could not be prevented by immediate implant placement. Soft tissue augmentaion techniques have been suggested in order to overcome the alterations of buccal bone during remodeling. Nevertheless, it is still inconclusive whether soft tissue augmentation procedures actually have a protective role in preserving buccal bone thickness in immediate implants.
Aim is to clinically and radiographically assess the effect of soft tissue grafting on buccal bone resorption and pink esthetics around immediately placed implants in maxillary anterior teeth after 24 months following implant placement. 18 non-restorable maxillary anterior teeth randomly assigned into 2 groups: (test group) immediately placed implants with simultaneous vascular interpositional periosteal connective tissue (VIP-CT) grafting versus non-augmented implant sites (control group). Buccal bone changes were assessed at implant placement (0) and at 4,9,12 and 24 months from baseline by specially manufactured device and at 24 months by cone beam computed tomography scans (CBCT). Pink esthetic score (PES) was evaluated at 6, 9, 12 and 24 months intervals. Pain and satisfaction were assessed through questionnaires to the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Implants + VIP graft. | Experimental | Procedure: VIP graftImmediate implants placed with simultaneous vascularized interpositional periosteal (VIP) connective tissue graft augmentation. |
| Immediate Implants only | No intervention | –Immediate Implants only without soft tissue augmentation. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
- Patients with healthy systemic condition.
- Buccal bone thickness should be at least 1mm.
- Availability of bone apical and palatal to the socket to provide primary stability.
- Good oral hygiene.
Key exclusion criteria (3 listed)
- Patients with signs of acute infection related to the area of interest.
- Current and former smokers
- Pregnant.
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 |
|---|---|---|
| VIP graftsurgical soft tissue grafting concomitant to implant placement | Procedure or surgery | Immediate Implants + VIP graft. |
Primary outcome
"PES" Pink Esthetic Score
Time frame: 2 years
esthetic assessment by the pink esthetic score introduced by furhauser et al 2005
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 17 Nov 2020.
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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.
Hani El Nahass, PhD study director
Cairo 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 VIP graft in people with Buccal Bone Loss in Immediate Implants, 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 3 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 17 Nov 2020. 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?
"PES" Pink Esthetic Score (time frame: 2 years). 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 17 Nov 2020.