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

Official title

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

Overview

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.

Interventions

• 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
• 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 restoratio

Primary outcome measures

• bucco-palatal dimensional ridge changes [Time frame: Pre-operative , day 1 , then 3,6 , 9 months later]

Secondary outcome measures (9)

• Pink esthetic score (PES) [Time frame: Baseline, 3 , 6,and 9 months]
• • Volumetric changes ( digital scanner ) [Time frame: Pre-operative ,day 1 , 3,6 ,and 9 months]
• • Mid facial mucosal recession (MFR) [Time frame: Pre-operative baseline and 3,6,9 months]
• • Labial bone thickness [Time frame: The labial bone thickness will be measured at day 1and 9 months later]
• • Soft tissue thickness (STT) [Time frame: measured at baseline and 9 months]
• Visual analogue scale measures postoperative pain (VAS) [Time frame: 3 days , 7 days ,and 14 days]
• • Probing depth [Time frame: Baseline and 9 months]
• • Plaque index [Time frame: Baseline and 9 months]
• • Bleeding index [Time frame: Baseline and 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• The British university in Egypt — Cairo

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. PMID 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. PMID 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. PMID 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. PMID 15882225

Identifiers

NCT: NCT07492576 · 25-050

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗