Immediate Implant and Bone GraftNCT03768297
Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implant Using Dual Zone Therapeutic Concept Versus Buccal Gap Fill to Bone Level
A study testing dual zone concept in people with Immediate Implant and Bone Graft, run by Cairo University.
Trial summary
Immediate implant placement in the esthetic zone is very challenging procedure although it is documented as a promising procedure (Berglundh, Persson and Klinge, 2002)(Cosyn et al., 2011). Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant and Bone Graft
- What is being tested?
- dual zone concept
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2018to 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have at least one non restorable tooth in the esthetic zone that needs to be extracted.
- Patients with healthy systemic condition.(Brightman. 1994)
- Patients aged from 20 to 45 years old.
- Buccal bone thickness should be at least 1mm. (Morton et al., 2014)
- Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014)
- Good oral hygiene.(Wiesner et al., 2010)
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- Accepts one year follow-up period (cooperative patients).
- Patient provides an informed consent.
- Adequate Inter-arch space for implant placement.
- favorable occlusion (no traumatic occlusion)
Who cannot join
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- Current and former smokers (Lambert, Morris and Ochi, 2000)
- Pregnant females.
About this study
Official title: Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implant Using Dual Zone Therapeutic Concept Versus Buccal Gap Fill to Bone Level.A Randomized Controlled Clinical Trial
Immediate implant placement in the esthetic zone is very challenging procedure although it is documented as a promising procedure (Berglundh, Persson and Klinge, 2002)(Cosyn et al., 2011). Extraction is usually accompanied by remodeling of the hard tissues which is more crucial in the anterior maxilla as it affects soft tissue esthetics(Araujo and Lindhe, 2005)(Covani et al., 2004)(Juodzbalys and Wang, 2007). It is well established that implant placement without filling the buccal gap leads to noticeable amount of bone loss at the alveolar contour(Botticelli, Berglundh and Lindhe, 2004)(Sanz et al., 2010). The protocol of immediate implant and temporization serves to provide acceptable esthetic results but soft tissue stability around the implant restoration is not always satisfactory(Noelken et al., 2018).Amount of soft tissue recession can be specified following immediate implant placement, even with flapless technique there is a limited risk of midfacial recession(Cosyn, Hooghe and De Bruyn, 2012).It was found that inadequate bone grafting in the facial defect increases the chance of mid facial recession(Le, Borzabadi-Farahani and Pluemsakunthai, 2014).
Read the detailed description
By definition, the dual zone can be divided into soft tissue zone and bone zone; the soft tissue zone is the vertical dimension change measured from the free gingival margin to the mid crest labially, the bone zone is the hard tissues measured from the crestal bone towards the apex(Chu et al., 2012). The concept of the dual zone aims to maintain the hard, soft tissue volume and the blood clot where the grafting material act as a scaffold containing them and this will enhance the initial healing compared to the classic protocol of bone filling till the buccal bone level(Chu et al., 2012). A recent study claims that the xenograft particles can be successfully incorporated within the soft tissue without inflammation enhancing the soft tissue profile(Araujo and Lindhe, 2005). The temporary restoration has shown socket sealing property which protect and contain the blood clot and the graft material enhancing healing,thus filling the gap without involvement of the soft tissue has been the rational for immediate implant placement(Trimpou G, Weigl P, Krebs M, 2010).The main benefit of the dual zone concept is maintaining the blood supply from the periosteum and endosteum producing maximum healing potential with preserving the soft tissue stability by filling the soft tissue zone with bone graft in addition to immediate temporization acting as socket seal(Chu et al., 2012).
- Conditions
- Immediate Implant and Bone Graft
- Being tested
- dual zone concept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual zone conceptProcedure or surgery
immediate implant with bone fill till soft tissue level
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with dual zone therapeutic concept | Experimental | Not described Receives: Procedure: dual zone concept |
| immediate implant with buccal bone fill | Active comparator | Not described Receives: Procedure: dual zone concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score
The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, softtissuecontour, alveolar process deficiency,soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score,with 2 being the best and 0 being thepoorest score.The mesial and distal papilla will be evaluatedfor completeness, incompleteness orabsence. All other variables will be assessedby comparison to a reference tooth.(Fürhauser et al., 2005)
Measured: 12 months post surgery
Secondary outcomes (5)
Buccal bone thickness
using a specially designed device that will be screwed to the fixture. (Merheb et al., 2016)
Measured: 12 months post surgery
Gingival Thickness
Will be measured using an anesthetic needle with a rubber stopper,transgingivally piercing tissues horizontally,perpendicular to the long axis of the tooth/implant until it contacts bone, at 9 different points; three readings: mesially, midbuccally and distally at three different levels; 2mm, 4mm and 6mm apical to the gingival margin.The lengthof the part of the instrument that penetratedinto the soft tissue is measured in mm.(Wiesner et al., 2010)
Measured: 12 months post surgery
Keratinized tissue width
Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.
Measured: 12 months post surgery
Post operative swelling
Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area), assessed during the first 7 postoperative days. (García et al., 2008)
Measured: 12 months post surgery
Post Surgical Patient Satisfaction: Questionnaire
A 3-item questionnaire is asked and the patients shall use a 7 point answer scale. (Kiyak et al., 1984)
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start20 Dec 2018 (estimated)
- Primary completion20 Nov 2019 (estimated)
- Study completion20 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant and Bone GraftStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RWGWanis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768297
- Sponsor's protocol ID
- 2508
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 7 Dec 2018
- 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 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Soft Tissue Esthetics Around Immediate Implant Using Dual Zone Therapeutic Concept Versus Buccal Gap Fill to Bone Level.A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03768297
- Acronym / sponsor ID
- 2508
- Conditions
- Immediate Implant and Bone Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2018 (estimated)
- Primary completion
- 20 Nov 2019 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 7 Dec 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.
Immediate implant placement in the esthetic zone is very challenging procedure although it is documented as a promising procedure (Berglundh, Persson and Klinge, 2002)(Cosyn et al., 2011). Extraction is usually accompanied by remodeling of the hard tissues which is more crucial in the anterior maxilla as it affects soft tissue esthetics(Araujo and Lindhe, 2005)(Covani et al., 2004)(Juodzbalys and Wang, 2007). It is well established that implant placement without filling the buccal gap leads to noticeable amount of bone loss at the alveolar contour(Botticelli, Berglundh and Lindhe, 2004)(Sanz et al., 2010). The protocol of immediate implant and temporization serves to provide acceptable esthetic results but soft tissue stability around the implant restoration is not always satisfactory(Noelken et al., 2018).Amount of soft tissue recession can be specified following immediate implant placement, even with flapless technique there is a limited risk of midfacial recession(Cosyn, Hooghe and De Bruyn, 2012).It was found that inadequate bone grafting in the facial defect increases the chance of mid facial recession(Le, Borzabadi-Farahani and Pluemsakunthai, 2014).
Detailed description
By definition, the dual zone can be divided into soft tissue zone and bone zone; the soft tissue zone is the vertical dimension change measured from the free gingival margin to the mid crest labially, the bone zone is the hard tissues measured from the crestal bone towards the apex(Chu et al., 2012). The concept of the dual zone aims to maintain the hard, soft tissue volume and the blood clot where the grafting material act as a scaffold containing them and this will enhance the initial healing compared to the classic protocol of bone filling till the buccal bone level(Chu et al., 2012). A recent study claims that the xenograft particles can be successfully incorporated within the soft tissue without inflammation enhancing the soft tissue profile(Araujo and Lindhe, 2005). The temporary restoration has shown socket sealing property which protect and contain the blood clot and the graft material enhancing healing,thus filling the gap without involvement of the soft tissue has been the rational for immediate implant placement(Trimpou G, Weigl P, Krebs M, 2010).The main benefit of the dual zone concept is maintaining the blood supply from the periosteum and endosteum producing maximum healing potential with preserving the soft tissue stability by filling the soft tissue zone with bone graft in addition to immediate temporization acting as socket seal(Chu et al., 2012).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant with dual zone therapeutic concept | Experimental | Procedure: dual zone concept |
| immediate implant with buccal bone fill | Active comparator | Procedure: dual zone concept |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients who have at least one non restorable tooth in the esthetic zone that needs to be extracted.
- Patients with healthy systemic condition.(Brightman. 1994)
- Patients aged from 20 to 45 years old.
- Buccal bone thickness should be at least 1mm. (Morton et al., 2014)
- Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014)
Key exclusion criteria (4 listed)
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- Current and former smokers (Lambert, Morris and Ochi, 2000)
- Pregnant females.
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 |
|---|---|---|
| dual zone conceptimmediate implant with bone fill till soft tissue level | Procedure or surgery | immediate implant with buccal bone fill, immediate implant with dual zone therapeutic concept |
Primary outcome
Pink Esthetic Score
Time frame: 12 months post surgery
The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, softtissuecontour, alveolar process deficiency,soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score,with 2 being the best and 0 being thepoorest score.The mesial and distal papilla will be evaluatedfor completeness, incompleteness orabsence. All other variables will be assessedby comparison to a reference tooth.(Fürhauser et al., 2005)
5 secondary outcomes
Buccal bone thickness
Time frame: 12 months post surgery
Gingival Thickness
Time frame: 12 months post surgery
Keratinized tissue width
Time frame: 12 months post surgery
Post operative swelling
Time frame: 12 months post surgery
Post Surgical Patient Satisfaction: Questionnaire
Time frame: 12 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing dual zone concept in people with Immediate Implant and Bone Graft, run by Cairo 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 10 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 7 Dec 2018. 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?
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?
Pink Esthetic Score (time frame: 12 months post surgery). 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 7 Dec 2018.