NCT03594019

Brief Summary

The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

July 11, 2018

Last Update Submit

May 14, 2019

Conditions

Tooth Fractures

Keywords

immediate implant placementconnective tissue graftsamll dehiscence

Outcome Measures

Primary Outcomes (1)

  • pink esthetic score （PES）

    An objective index introduced by Furhauser et al. 2005

    1 year

Secondary Outcomes (4)

  • mucosal recession

    1 year

  • marginal bone loss

    1 year

  • pocket probing depth

    1 year

  • bleeding on probing

    1 year

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished.

Procedure: Connective tissue graftProcedure: Immediate implant placement

Test Group

EXPERIMENTAL

Patients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished.

Procedure: socket shield techniqueProcedure: Immediate implant placement

Interventions

Connective tissue graftPROCEDURE

Connective tissue graft (CTG) is an oral and maxillofacial surgical procedure first described by Alan Edel in 1974. It includes the preparation the recipient site of tissue exhibiting recession by incising the gingival, obtaining the CTG from the donor site, securing the CTG at the recipient site and suturing the incised gingival tissue at both the donor and recipient sites.

Control Group
socket shield techniquePROCEDURE

The procedure is used to split the teeth and preserve the buccal part

Test Group
Immediate implant placementPROCEDURE

The implant will be placed in the frest socket immediately after tooth extraction

Control GroupTest Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （\<2mm vertical bone loss and \<5mm horizontal bone loss） Patients with natural teeth adjacent to implant site

You may not qualify if:

  • Uncontrolled periodontal diseases Heavy smokers (\>10 cigarettes/day) Unwilling to participate in the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, 200011, China

RECRUITING

MeSH Terms

Conditions

Tooth Fractures

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Central Study Contacts

Junyu Shi, PhD

CONTACT

081 53315299sakyamuni_jin@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

February 1, 2019

Primary Completion

December 20, 2021

Study Completion

February 1, 2022

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations

CN(1)