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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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.

Egypt1 site

ElAskary dental center
Alexandria

Other trials in Egypt

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 groups in NCT05381467
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.

1 Mar 202215 Dec 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
Implant
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer

All Immediate Implants trials

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.

Detailed description

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

Related trials for Immediate Implants

Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
Implant
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer

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?

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.