Midfacial Gingival Margin Changes Following Immediate Implants.

Not Applicable

Completed

• Conditions: Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement
• Interventions: Procedure: Connective tissue graft /Bone graft/ Customized HA

• Registration Number: NCT05975515
• Lead Sponsor: Cairo University

Brief Summary

Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics

Detailed Description

Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).

Study Timeline

• Study Start: 2022-01-13
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-30
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Patient-related criteria:

  • Adults at or above the age of 18.
  • Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
  • The failing tooth will have adjacent and opposing natural teeth.
  • Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
  • Able to tolerate surgical periodontal procedures.
  • Good oral hygiene.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accepts the one-year follow-up period.

Teeth related criteria:

• Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
• Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
• Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

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Exclusion Criteria

• Patients diagnosed with periodontal diseases.
• Current or previous smokers.
• Pregnant and lactating females.
• Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
• Patients with active infection related at the site of implant/bone graft placement.
• Patients with parafunctional habits

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate implant placement with CTG and customized healing abutment.	Connective tissue graft /Bone graft/ Customized HA	Group 3 (intervention 2 group): immediate implant placement with customized healing abutment
immediate implant placement with bone grafts till crest	Connective tissue graft /Bone graft/ Customized HA	Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment.
immediate implant placement with customized healing abutment	Connective tissue graft /Bone graft/ Customized HA	Group 2 (intervention 1 group): Immediate implant placement with CTG and customized healing abutment.

Primary Outcome Measures

Name	Time	Method
Midfacial Gingival Margin Changes	12 months	will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.

Secondary Outcome Measures

Name	Time	Method
Bone labial to the implant	12 months	Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland.
Volumetric analysis of buccal contour&Total Volume	12 months	To evaluate tissue volume changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin, at 3, 6 and 12 months and will be compared to the presurgical scanned casts

Trial Locations

Locations (1)

IDCE; 🇪🇬 Cairo, Egypt