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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Immediate Implant Placement
• Intervention / Treatment: Device: GBR surgery using magnesium Shield; Procedure: Dual Zone concept (DZ) technique

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rim M Ghanem, Bachelor degree of dentistry; Phone Number: 0106037279; Email: rim.mazen@bue.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • The british university in egypt
    • Contact: Dalia G Ghalwash, Professor; Phone Number: 0100 5120159; Email: dalia.ghalwash@bue.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: magnesium shield (GBR); 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; 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 .; Other Names: Novamag; Immidate implant
Active Comparator: Dual Zone concept (DZ) technique; ( 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 3 , 6,and 9 months
• 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.	Pre-operative baseline and 3,6,9 months
• 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).	The labial bone thickness will be measured at day 1and 9 months later
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)	3 days , 7 days ,and 14 days
• 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.	Baseline and 9 months
• 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).	Baseline and 9 months
• Bleeding index	clinical index used to evaluate gingival inflammation by measuring bleeding after gentle probing.; A periodontal probe is gently inserted into the gingival sulcus.; The probe is moved along the gingival margin with light pressure.; The site is observed for bleeding within about 10-30 second	Baseline and 9 months
• 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.	Pre-operative ,day 1 , 3,6 ,and 9 months
• 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 at baseline and 9 months

Collaborators and Investigators

• Sponsor: British University In Egypt

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• . 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): January 29, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Magnesium shield ,; Immidate implant; dual zone concept with immediate implant.
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 25-050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No