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OpenTrials
Completed

NCT Number: NCT05975515

Midfacial Gingival Margin Changes Following Immediate Implants.

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDCE

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Connective tissue graft /Bone graft/ Customized HA

Procedure

Soft tissue management and augmentation

Other names: Customized Healing abutment

Primary outcomes

  1. Midfacial Gingival Margin Changes

    Time frame: 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 outcomes

  1. Bone labial to the implant

    Time frame: 12 months

    Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland.

  2. Volumetric analysis of buccal contour&Total Volume

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Soft Tissue Volume on Midfacial Gingival Margin Alterations Following Immediate Implant Placement in the Esthetic Zone: A 1-Year Randomized Clinical and Volumetric Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2023
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.