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

NCT07492576 | Recruiting DMC

• 1 other identifier: 25-050
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

Immediate Implant Placement

Keywords

Magnesium shield ,; Immidate implant; dual zone concept with immediate implant.

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Pink esthetic score (PES)

  Baseline, 3 , 6,and 9 months

• • Volumetric changes ( digital scanner )

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

• • Mid facial mucosal recession (MFR)

  Pre-operative baseline and 3,6,9 months

• • Labial bone thickness

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

• • Soft tissue thickness (STT)

  measured at baseline and 9 months

Study Arms (2)

magnesium shield (GBR)

EXPERIMENTAL

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 .

Device: GBR surgery using magnesium Shield

Dual Zone concept (DZ) technique

ACTIVE 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.

Procedure: Dual Zone concept (DZ) technique

Interventions

GBR surgery using magnesium Shield DEVICE

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 .

Also known as: Novamag, Immidate implant

magnesium shield (GBR)

Dual Zone concept (DZ) technique PROCEDURE

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 .

Dual Zone concept (DZ) technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British university in Egypt

Cairo, Egypt

RECRUITING

Related Publications (4)

• 4. E. Gurbuz, E. Ceylan: 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; 54: 356-364. © 2024.

  BACKGROUND

• 3. Araújo MG, Wennström JL, Lindhe J. Modeling of the buccal and lingual bone walls of fresh extraction sites following implant installation. Clin Oral Implants Res. 2006;17:606-14. https://doi.org/10.1111/J.1600-0501.2006.01315.X.

  BACKGROUND

• 2.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. PMID: 28000278.

  BACKGROUND

• . Araújo MG, Sukekava F, Wennström JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005;32:645-52. https://doi.org/10.1111/J.1600-051X.2005.00726.X.

  BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Rim M Ghanem, Bachelor degree of dentistry

CONTACT

0106037279; rim.mazen@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rim Mazen Ghanem , demonstrator , faculty of dentistry, the British university in Egypt

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 25, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: April 1, 2026

Record last verified: 2025-08

Locations

EG (1)