AzTrials
AzTrials

Immediate Implant PlacementNCT07492576

Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management

A study testing GBR surgery using magnesium Shield and Dual Zone concept (DZ) technique in people with Immediate Implant Placement, run by British University In Egypt at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Will (GBR) by application of magnesium membrane with immediate implant will have more volume gain , higher pink esthetic score, and lower visual analogue scale than dual zone grafting technique? Several methods have been suggested for the preservation of post-extraction resorption and promoting an increase in the bone… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Immediate Implant Placement
What is being tested?
GBR surgery using magnesium Shield and Dual Zone concept (DZ) technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteEgypt
Study dates
19 Mar 2026to 29 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-60 years of age
  • Patients have hopeless maxillary teeth, a thin buccal plate of bone ≤1 mm and intact overlying soft tissue intact overlying soft tissues in aesthetic zone (EDS-2, Kan classification)
  • Periodontally healthy (good oral hygiene)
  • Medically controlled patient

Who cannot join

  • Smokers
  • patients with systemic diseases
  • history of chemotherapy or radiotherapy within the past 2 years.
  • Acute infection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rim M Ghanem, Bachelor degree of dentistry contact

0106037279

rim.mazen@bue.edu.eg

Egypt1 site, 1 recruiting
  • The British university in Egypt

    Cairo

    Dalia G Ghalwash, Professor, 0100 5120159, dalia.ghalwash@bue.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management: a Randomized Controlled Clinical Trial

Will (GBR) by application of magnesium membrane with immediate implant will have more volume gain , higher pink esthetic score, and lower visual analogue scale than dual zone grafting technique? Several methods have been suggested for the preservation of post-extraction resorption and promoting an increase in the bone density with immediate implant placement. one of these techniques is the dual zone concept (DZ), atraumatic tooth extraction using peristomes and luxators, implant placement along with the bone grafting material applied to both the bone and tissue zones.

The aim of (DZ) is to augment the soft tissue using a bone graft to avoid mucosal recession after implant placement thus keeping the gingival contour providing optimal soft tissue aesthetic.

Read more

The use of magnesium membrane in combination with inorganic bovine bones will be placed between the membrane and immediate implant. This allows implant placement while simultaneously rehabilitating the entire socket, due to its unique material properties, a magnesium membrane is used to rebuild, support the buccal or oral walls in compromised sockets, and promotes cortical bone growth . Many techniques available for preserving the bone of the socket post-tooth extraction, but in comparison to the current materials and techniques used , magnesium membrane is completely resorbable and does not require second surgery to be removed; it is synthetic and therefore does not need to be sourced from an additional surgical. magnesium membrane is excellent in providing both esthetic and functional outcomes that meet patient expectations.

The procedure involves flapless approach in which atraumatic tooth extraction using peristomes and forceps will be performed to preserve the available alveolar bone. The implant site will be prepared, and the implant will be placed palatal and 3-4m.m apical to the free gingival margin (FGM). magnesium membrane will be placed between the soft tissue and thin buccal wall. The edges of the membrane will be shaped and flattened with sculptor to prevent perforation of the soft tissue, and a layer off inorganic bovine bone will be placed between the e buccal wall and implant. Then immediate provisional restoration will be constructed and placed to allow an ideal final crown mimicking the natural emergence profile.

Being tested
GBR surgery using magnesium Shield, Dual Zone concept (DZ) technique
Keywords
Magnesium shield ,, Immidate implant, dual zone concept with immediate implant.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GBR surgery using magnesium ShieldDevice

    Also called Novamag, Immidate implant

    Atraumatic flapless tooth extraction using periotomes and forceps will be performed to preserve the available labial bone wall the alveolus will be curetted with a curette, and the remaining inflammatory tissue will be removed. Then, the implant site will be prepared, and the implant will be inserted . A novel magnesium membrane will be placed between thin labial bone wall and soft tissue. the membrane will be cutted and shaped to the proper size using scissors. The edges of the membrane will be shaped and flattened with the sculptor to prevent perforation of the soft tissue, and a layer of bone will be placed between implant and buccal wall. The socket will be sealed with a chair-side fabricated provisional restoration on temporary abutment .

  • Dual Zone concept (DZ) techniqueProcedure or surgery

    Atraumatic flapless tooth extraction using peristomes and luxators, then Osteotomy site preparation will be done according to the manufacturers.

    instructions followed by immediate implant placement. The implant will be 3-4m.m apical to the free gingival margin (FGM) , engaging intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which will be set to be at least 35 Ncm to allow non- functional immediate loading of chair- side provisional restorations fabricated on abutments, to allow sealing the socket orifice and maintain the original socket architecture , the gap labial to the implant will be filled with bone both the bone and tissue zones till the free gingival margin level to reduce the change in the contour around implants, then the chair side fabricated provisional restoration will be placed .

Study groups in NCT07492576
Study groupRoleWhat they receive
magnesium shield (GBR)ExperimentalAtraumatic flapless tooth extraction using periotomes and forceps will be performed to preserve the available labial bone wall the alveolus will be curetted with a curette, and the remaining inflammatory tissue will be removed. Then, the implant site will be prepared, and the implant will be inserted . A novel magnesium membrane will be placed between thin labial bone wall and soft tissue. the membrane will be cutted and shaped to the proper size using scissors. The edges of the membrane will be shaped and flattened with the sculptor to prevent perforation of the soft tissue, and a layer of bone will be placed between implant and buccal wall. The socket will be sealed with a chair-side fabricated provisional restoration on temporary abutment .
Receives: Device: GBR surgery using magnesium Shield
Dual Zone concept (DZ) techniqueActive comparator( control group ) Atraumatic flapless tooth extraction using peristomes and luxators, then Osteotomy site preparation will be done according to the manufacturers. instructions followed by immediate implant placement. The implant will be 3-4m.m apical to the free gingival margin (FGM) , engaging intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which will be set to be at least 35 Ncm to allow non- functional immediate loading of chair- side provisional restorations fabricated on abutments, to allow sealing the socket orifice and maintain the original socket architecture , the gap labial to the implant will be filled with bone both the bone and tissue zones till the free gingival margin level to reduce the change in the contour around implants, then the chair side fabricated provisional restoration will be placed.
Receives: Procedure: Dual Zone concept (DZ) technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bucco-palatal dimensional ridge changes

    The Bucco-palatal dimensional ridge alterations were assessed via digital scans to assess the difference and changes in the overall ridge dimensions (mm). Reference points were assigned in the baseline measurements of the scans using the Standard Triangle Language (STL) files of the models obtained via digital scanning to allow standardized comparisons after 3,6, and 9 months. The 3D software allowed the alignment of the reference points identified on the models.

    Measured: Pre-operative , day 1 , then 3,6 , 9 months later

Secondary outcomes (9)
  1. Pink esthetic score (PES)

    Pink esthetic score will be recorded for five variables: "mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site". A score of 2, 1, or 0 will be assigned to all five PES parameters.

    The two papillary scores (mesial and distal) will be assessed for the complete presence (score 2), incomplete presence (score 1) or absence (score0) of papillary tissue. The curvature of the facial soft tissue line, also defined as the line of emergence of the implant restoration from the soft tissues, will be evaluated as being identical (score 2 ), slightly different (score 1), or markedly different (score 0) compared to the natural control tooth and thus, provided a natural symmetrical or disharmonious appearance and in comparison to the contralateral tooth in terms of an identical vertical level (score 2), a slight (<1 mm) discrepancy (score 1), or a major (>1 mm) discrepancy

    Measured: Baseline, 3 , 6,and 9 months

  2. • Volumetric changes ( digital scanner )

    To assess the volumetric differences between the baseline, 3, 6 and 9 months postoperatively, digital replica using scanner. Digital replicas were produced resembling various time intervals during treatment. Superimposing the different replicas of each case utilizing the best fit algorithm by using reference points from the tooth surfaces. The implant site region was delineated by the mucogingival line, the mesial and distal papillary midline, and the alveolar crest. Thus, alterations in volume between the digitized superimposed replicas could be recorded.

    Measured: Pre-operative ,day 1 , 3,6 ,and 9 months

  3. • Mid facial mucosal recession (MFR)

    changes were assessed by three measurements, taken at the tip of the mesial papillae, tip of the distal papillae, and mid-facial gingival margin, preoperative, once at baseline and were compared to measurements after ,3, 6, and 9 months.

    Measured: Pre-operative baseline and 3,6,9 months

  4. • Labial bone thickness

    Assessed on the sagittal section of the CBCT at three points: the implant platform (crestal thickness), half of the implant length (middle thickness) and implant apex (apical thickness).

    Measured: The labial bone thickness will be measured at day 1and 9 months later

  5. • Soft tissue thickness (STT)

    using an anesthetic needle with rubber stopper to pierce the gingiva horizontally and perpendicular to the long axis of the tooth till bone contact 2mm coronal to the MGJ and in the mid distance mesiodistally. The part of the instrument penetrating into soft tissue will be measured in mm.

    Measured: measured at baseline and 9 months

  6. Visual analogue scale measures postoperative pain (VAS)

    Pain score is reported by the patient directly through The Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain)

    Measured: 3 days , 7 days ,and 14 days

  7. • Probing depth

    Probing depth is the distance from the gingival margin to the base of the sulcus or periodontal pocket, measured using a periodontal probe.

    Measured: Baseline and 9 months

  8. • Plaque index

    simple method used to record the presence of dental plaque on tooth surfaces. It is commonly called the O'Leary Plaque Control Record (PCR).

    Measured: Baseline and 9 months

  9. • Bleeding index

    clinical index used to evaluate gingival inflammation by measuring bleeding after gentle probing.

    1. A periodontal probe is gently inserted into the gingival sulcus.
    2. The probe is moved along the gingival margin with light pressure.
    3. The site is observed for bleeding within about 10-30 second

    Measured: Baseline and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start19 Mar 2026
  3. Primary completion29 Dec 2026 (estimated)
  4. Study completion29 Jan 2027 (estimated)

Resources

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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07492576
Sponsor's protocol ID
25-050
Status last verified
Aug 2025
First submitted
13 Mar 2026
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gurbuz E, Ceylan E. Comparison of a non-grafted socket shield technique with guided bone regeneration in immediate implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2025 Apr;54(4):356-364. doi: 10.1016/j.ijom.2024.11.009. Epub 2024 Dec 7.

    PubMed 39648089
  • Araujo MG, Wennstrom JL, Lindhe J. Modeling of the buccal and lingual bone walls of fresh extraction sites following implant installation. Clin Oral Implants Res. 2006 Dec;17(6):606-14. doi: 10.1111/j.1600-0501.2006.01315.x.

    PubMed 17092217
  • Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.

    PubMed 28000278
  • Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.

    PubMed 15882225

Questions about this trial

What is this clinical trial studying?

A study testing GBR surgery using magnesium Shield and Dual Zone concept (DZ) technique in people with Immediate Implant Placement, run by British University In Egypt 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 4 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rim M Ghanem, Bachelor degree of dentistry (0106037279, rim.mazen@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bucco-palatal dimensional ridge changes (time frame: Pre-operative , day 1 , then 3,6 , 9 months later). 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 NCT07492576, which also lists 4 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 1 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in