Immediate Implant Placement With or Without Buccal Bone Dehiscence

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed
• Intervention / Treatment: Procedure: gap filling; Procedure: connective tissue graft; Procedure: flap elevation and guided bone regeneration

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hositpal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in need of single implant replacement

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group1; socket with intact buccal bone plate	Procedure: gap filling; to use biomaterials to fill the jumping gap; Procedure: connective tissue graft; to change the soft tissue phenotype by connective tissue graft
group 2; socket with damaged buccal bone plate	Procedure: gap filling; to use biomaterials to fill the jumping gap; Procedure: connective tissue graft; to change the soft tissue phenotype by connective tissue graft; Procedure: flap elevation and guided bone regeneration; to rebuild the alveolar ridge convexity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mucosa recession	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	baseline to 1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth	peri-implant probing depth detected by periodontal probe examined by a peridontal probe at six sites around the crown	baseline to 1-year
bleeding on probing	percentage of sites with bleeding on probing examined by a peridontal probe at six sites around the crown	baseline to 1-year
Pink Esthetic Score (0-14)	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.	baseline to 1-year
thickness of buccal bone plate	the distance between the implant's facial contour and the outside surface of the buccal bone measured by cone beam computor tomograph.	baseline to 1-year

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SH9H2022-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No