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OpenTrials
Completed

NCT Number: NCT05445986

Immediate Implant Placement With or Without Buccal Bone Dehiscence

Immediate implant placement has been advantageous in terms of reduced treatment time and fewer surgical interventions. Given the fact that the level of buccal bone acts as a major prognostic factor for IIP, the indications for immediate implant placement were suggested to be limited to intact alveolar sockets.In recent years, many attempts have been performed to compensate for the alveolar ridge resorption in immediate implant placement in compromised sockets. The clinical outcomes of IIP with guided tissue regeneration and connective tissue grafting using papilla preservation technique in compromised extraction sockets has not been previously reported.

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Key information

Conditions

Dental Implant Failed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Ninth People's Hositpal

Shanghai, Shanghai Municipality, 200011, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with anterior failing teeth (from cainine to cainine) with the presence of neighbouring teeth
  • sufficient bone volume to achieve primary stability at implant insertion

Exclusion criteria

  • with uncontrolled periodontitis
  • heavy smoker (>10 cigarettes/day)
  • unwilling to sign the informed consent

Treatment and study plan

flap elevation and guided bone regeneration

Procedure

to rebuild the alveolar ridge convexity

gap filling

Procedure

to use biomaterials to fill the jumping gap

connective tissue graft

Procedure

to change the soft tissue phenotype by connective tissue graft

Primary outcomes

  1. mucosa recession

    Time frame: baseline to 1-year

    The height of the crown was measured by a peridontal probe in mid-facial aspect. The difference of the height of the crown over time was calculated as mucosa recession

Secondary outcomes

  1. probing depth

    Time frame: baseline to 1-year

    peri-implant probing depth detected by periodontal probe examined by a peridontal probe at six sites around the crown

  2. bleeding on probing

    Time frame: baseline to 1-year

    percentage of sites with bleeding on probing examined by a peridontal probe at six sites around the crown

  3. Pink Esthetic Score (0-14)

    Time frame: baseline to 1-year

    Seven parameters were assessed:mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and soft tissue texture. Each parameter was scored as 2,1,0.

  4. thickness of buccal bone plate

    Time frame: baseline to 1-year

    the distance between the implant's facial contour and the outside surface of the buccal bone measured by cone beam computor tomograph.

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

Clinical, Radiographic and Aesthetic Evaluation of Immediate Implant Placement With or Without Buccal Bone Dehiscence in the Anterior Maxilla

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2022
Registry last updated
Jul 6, 2022

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.

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