NCT03319758

Brief Summary

The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress87%
May 2016Nov 2027

Study Start

First participant enrolled

May 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

10.5 years

First QC Date

September 14, 2017

Last Update Submit

February 8, 2021

Conditions

Jaw, Edentulous, PartiallyAcquired Absence of Single Tooth

Keywords

bone augmentationestheticsimmediate implantbuccal bone defects

Outcome Measures

Primary Outcomes (1)

  • Radiographic bone volume

    Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Up to 10 years after baseline

Secondary Outcomes (10)

  • Change of Pink and white esthetic scores (PES/WES)

    Change from baseline up to 10 years after implantation

  • Visual analogue scale (VAS)

    Up to 10 years after baseline

  • Oral health impact profile shortened version (OHIP-I)

    Up to 10 years after baseline

  • Buccal marginal recession

    Up to 10 years after baseline

  • Papilla volume

    Up to 10 years after baseline

  • +5 more secondary outcomes

Study Arms (1)

thin or dehiscences buccal plate

EXPERIMENTAL

Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.

Procedure: buccal bone augmentation

Interventions

buccal bone augmentationPROCEDURE

Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited.

thin or dehiscences buccal plate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70-year-old;
  • Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);
  • Single maxillary anterior teeth (canine to canine);
  • Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)；
  • Presence of adjacent nature tooth;
  • Good compliance;
  • No palatal vertical bone loss;
  • Good oral hygiene.

You may not qualify if:

  • Uncontrolled periodontal or systemic disease;
  • General psychiatric contraindications;
  • More than 20 cigarettes per day;
  • History of head and neck radiotherapy；
  • Pregnant or expecting to be pregnant;
  • Patients with local or generalized healing limitations;
  • Bruxism or other destructive parafunctional habits;
  • Drug abuse or alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (3)

  • Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.

    PMID: 25916859RESULT

  • Barone A, Ricci M, Romanos GE, Tonelli P, Alfonsi F, Covani U. Buccal bone deficiency in fresh extraction sockets: a prospective single cohort study. Clin Oral Implants Res. 2015 Jul;26(7):823-30. doi: 10.1111/clr.12369. Epub 2014 Mar 31.

    PMID: 24684275RESULT

  • Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. Dental implants with versus without peri-implant bone defects treated with guided bone regeneration. J Clin Exp Dent. 2015 Jul 1;7(3):e361-8. doi: 10.4317/jced.52292. eCollection 2015 Jul.

    PMID: 26330931RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Baoxin Huang, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2017

First Posted

October 24, 2017

Study Start

May 1, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

CN(1)