NCT05445986

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

June 27, 2022

Last Update Submit

June 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • probing depth

    baseline to 1-year

  • bleeding on probing

    baseline to 1-year

  • Pink Esthetic Score (0-14)

    baseline to 1-year

  • thickness of buccal bone plate

    baseline to 1-year

Study Arms (2)

group1

socket with intact buccal bone plate

Procedure: gap fillingProcedure: connective tissue graft

group 2

socket with damaged buccal bone plate

Procedure: flap elevation and guided bone regenerationProcedure: gap fillingProcedure: connective tissue graft

Interventions

to rebuild the alveolar ridge convexity

group 2
gap fillingPROCEDURE

to use biomaterials to fill the jumping gap

group 2group1

to change the soft tissue phenotype by connective tissue graft

group 2group1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in need of single implant replacement

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hositpal

Shanghai, Shanghai Municipality, 200011, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 6, 2022

Study Start

August 1, 2019

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

July 6, 2022

Record last verified: 2022-06

Locations