Immediate ImplantsNCT05381467
Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy
A study testing immediate implant placement with The Dual-Zone Therapeutic Concept and Immediate implant placement with the bone shielding concept in people with Immediate Implants and Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Implants, Alveolar Bone Loss, Dual Zone Technique
- What is being tested?
- immediate implant placement with The Dual-Zone Therapeutic Concept and Immediate implant placement with the bone shielding concept
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 15 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult (>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone
- type I socket (intact but thin labial plate of bone and intact overlying soft tissues)
- adequate palatal bone
- ≥3 mm apical bone to engage the immediately placed implants
- optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.
Who cannot join
- smokers
- pregnant women
- patients with systemic diseases
- periodontal disease, gingival recession
- infected sockets
- periapical pathosis and history of chemotherapy or radiotherapy within the past 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bone Shielding Versus Dual Zone Concept in Treating Thin Walled Fresh Extraction Sockets With Immediate Implant Placement Soft and Hard Tissue Changes A Randomized Clinical Trial
Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.
Read the detailed description
It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype
- Conditions
- Immediate Implants, Alveolar Bone Loss, Dual Zone Technique, the Bone Shielding Concept, Esthetic Zone
- Being tested
- immediate implant placement with The Dual-Zone Therapeutic Concept, Immediate implant placement with the bone shielding concept
- Keywords
- esthetic zone, soft tissue augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with The Dual-Zone Therapeutic ConceptProcedure or surgery
After tooth removal, implant placement, bone grafting, and screw retained provisional restoration, the contour of the ridge can change. Using dual zone grafting was claimed to minimize contour change associated with immediate anterior implants. In this technique. The implant should be placed in an optimal 3 dimensional mode . Xenograft, will be used in the gap to graft the bone and tissue zones, . The graft material helps serve as a scaffold to maintain hard- and soft-tissue volume as well as blood clot for initial healing.
Immediate implant placement with the bone shielding conceptProcedure or surgery
After atraumatic tooth extraction using periotomes and luxators , socket curettage and cleaning simultaneously using an irrigation curette will be performed. Sulcular dissection of the attached tissue close to the socket orifice incisal and apically will be done using periotome to create a tunnel via the socket orifice. Dental implant will be placed. complete access of the labial plate of bone where all the regenerative materials will be performed to have the bone sheild delivered. A membrane will be inserted to the labial tunnel and tacked using 2 membrane tacks.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with The Dual-Zone Therapeutic Concept | Active comparator | Not described Receives: Procedure: immediate implant placement with The Dual-Zone Therapeutic Concept |
| Immediate implant placement with the bone shielding concept | Experimental | Not described Receives: Procedure: Immediate implant placement with the bone shielding concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score
Pink Esthetic Score 1-14 score PES
Measured: 6 months
Secondary outcomes (3)
labial bone thickness
radiographic CBCT
Measured: 6 months
Peri-implant probing depth
mm
Measured: 6 months
Implant failure
yes/No
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Mar 2022
- Primary completion15 Nov 2022
- Study completion15 Dec 2022
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
- Investigators
- Abdelsalam El Askary, Principal investigator, private practice, Alexandria, EgyptNoha A Ghallab, PhD, Study chair, Professor in the department of oral Medicine & Periodontology, Cairo UniversityNesma M shemais, PhD, Study director, Lecturer in the department of oral Medicine & Periodontology, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381467
- Sponsor's protocol ID
- AAN.1
- Status last verified
- May 2023
- First submitted
- 11 May 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elaskary A, Ghallab N, Thabet A, Shemais N. The bone shielding versus dual-zone concept in treating thin-walled fresh extraction sockets with immediate implant placement: Soft and hard tissue changes. A randomized clinical trial. Clin Implant Dent Relat Res. 2024 Feb;26(1):66-77. doi: 10.1111/cid.13275. Epub 2023 Sep 5.
PubMed 37669913
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bone Shielding Versus Dual Zone Concept in Treating Thin Walled Fresh Extraction Sockets With Immediate Implant Placement Soft and Hard Tissue Changes A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05381467
- Acronym / sponsor ID
- AAN.1
- Conditions
- Immediate Implants, Alveolar Bone Loss, Dual Zone Technique, the Bone Shielding Concept, Esthetic Zone
- Keywords
- esthetic zone, soft tissue augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 19 May 2022 (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 has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.
Detailed description
It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype
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 placement with The Dual-Zone Therapeutic Concept | Active comparator | Procedure: immediate implant placement with The Dual-Zone Therapeutic Concept |
| Immediate implant placement with the bone shielding concept | Experimental | Procedure: Immediate implant placement with the bone shielding concept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult (>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone
- type I socket (intact but thin labial plate of bone and intact overlying soft tissues)
- adequate palatal bone
- ≥3 mm apical bone to engage the immediately placed implants
- optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.
Key exclusion criteria (6 listed)
- smokers
- pregnant women
- patients with systemic diseases
- periodontal disease, gingival recession
- infected sockets
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 |
|---|---|---|
| immediate implant placement with The Dual-Zone Therapeutic ConceptAfter tooth removal, implant placement, bone grafting, and screw retained provisional restoration, the contour of the ridge can change. Using dual zone grafting was claimed to minimize contour change associated with immediate anterior implants. In this technique. The implant should be placed in an optimal 3 dimensional mode . Xenograft, will be used in the gap to graft the bone and tissue zones, . The graft material helps serve as a scaffold to maintain hard- and soft-tissue volume as well as blood clot for initial healing. | Procedure or surgery | immediate implant placement with The Dual-Zone Therapeutic Concept |
| Immediate implant placement with the bone shielding conceptAfter atraumatic tooth extraction using periotomes and luxators , socket curettage and cleaning simultaneously using an irrigation curette will be performed. Sulcular dissection of the attached tissue close to the socket orifice incisal and apically will be done using periotome to create a tunnel via the socket orifice. Dental implant will be placed. complete access of the labial plate of bone where all the regenerative materials will be performed to have the bone sheild delivered. A membrane will be inserted to the labial tunnel and tacked using 2 membrane tacks. | Procedure or surgery | Immediate implant placement with the bone shielding concept |
Primary outcome
Pink Esthetic Score
Time frame: 6 months
Pink Esthetic Score 1-14 score PES
3 secondary outcomes
labial bone thickness
Time frame: 6 months
Peri-implant probing depth
Time frame: 6 months
Implant failure
Time frame: 6 months
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 9 May 2023.
- Derived from this study: PubMed 37669913Elaskary A, Ghallab N, Thabet A, Shemais N. The bone shielding versus dual-zone concept in treating thin-walled fresh extraction sockets with immediate implant placement: Soft and hard tissue changes. A randomized clinical trial. Clin Implant Dent Relat Res. 2024 Feb;26(1):66-77. doi: 10.1111/cid.13275. Epub 2023 Sep 5.
- Individual participant dataSharing planned: No
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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.
Abdelsalam El Askary principal investigator
private practice, Alexandria, Egypt
Noha A Ghallab, PhD study chair
Professor in the department of oral Medicine & Periodontology, Cairo University
Nesma M shemais, PhD study director
Lecturer in the department of oral Medicine & Periodontology, 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 immediate implant placement with The Dual-Zone Therapeutic Concept and Immediate implant placement with the bone shielding concept in people with Immediate Implants and Alveolar Bone Loss, 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 6 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 9 May 2023. 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?
Pink Esthetic Score (time frame: 6 months). 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 NCT05381467, 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 9 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.