ClinicalTrials.gg
Active, not recruitingNCT03319758Updated Feb 9, 2021

Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

An interventional study of buccal bone augmentation in Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2016, registered Sep 2017).

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Jaw, Edentulous, Partially with a site in China — 2 open to participants now, 3 under way, none of them phase 3. Jaw, Edentulous, Partially · China.

Planned enrollment
10th of 10
15 · median 44
Started
2016
with 3 others
No phase
10 of 12
2 open now
Registered
12th of 12
by date
Lead sponsor
3 of 12
Sun Yat-sen University

Among the 12 studies in Jaw, Edentulous, Partially with a site in China, this one is the 10th largest by planned enrollment of the 10 interventional ones that give a count, is one of 4 that started in 2016, is one of 10 with no phase, and was the 12th registered.

Jaw, Edentulous, Partially

76 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.

Browse Jaw, Edentulous, Partially studies →

Open to participants now

2 of the 12 studies in Jaw, Edentulous, Partially with a site in China are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 6 Jaw, Edentulous, Partially studies recruiting now, 4 set no upper age limit and 1 stops at 75 or younger; none take children under 18; 2 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Jaw, Edentulous, Partially with a site in China, or all of them as a file.
02

Study 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.

Read the detailed description

The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. 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. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

03

Conditions studied

  • Jaw, Edentulous, Partially
  • Acquired Absence of Single Tooth

Keywords

  • bone augmentation
  • esthetics
  • immediate implant
  • buccal bone defects
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

The inclusion criteria were as follows:

  1. 18 to 70-year-old;
  2. Stable periodontal and systemic health ( classification I or II);
  3. Single maxillary anterior teeth (canine to canine);
  4. Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4);
  5. Presence of adjacent nature tooth;
  6. Good compliance;
  7. No palatal vertical bone loss;
  8. Good oral hygiene.

Exclusion criteria are as follow:

  1. Uncontrolled periodontal or systemic disease;
  2. General psychiatric ;
  3. More than 20 cigarettes per day;
  4. History of head and neck radiotherapy;
  5. Pregnant or expecting to be pregnant;
  6. Patients with local or generalized healing limitations;
  7. Bruxism or other destructive parafunctional habits;
  8. Drug abuse or alcohol abuse.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    thin or dehiscences buccal plate

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

    Procedure: buccal bone augmentation

Interventions

  • Procedurebuccal bone augmentation

    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.

06

What researchers measure

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.

    Time frame: Up to 10 years after baseline

Secondary outcomes

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

    Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Change from baseline up to 10 years after implantation

  2. Visual analogue scale (VAS)

    A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement

    Time frame: Up to 10 years after baseline

  3. Oral health impact profile shortened version (OHIP-I)

    A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  4. Buccal marginal recession

    Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  5. Papilla volume

    Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  6. Width of keratinized gingiva

    Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  7. Implant survival

    Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  8. Probing depth

    Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  9. Modified plaque index

    Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

  10. Modified bleeding index

    Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

    Time frame: Up to 10 years after baseline

07

Study locations

1 site
  • Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University
    Guangzhou, Guangdong 510000, China
08

References and documents

Publications

  • 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. PubMed 25916859 ↗
  • 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. PubMed 24684275 ↗
  • 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. PubMed 26330931 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2016 (actual). Primary completion is estimated for Nov 2026, 126 months after the start.

Of 34 interventional studies with no phase under Jaw, Edentulous, Partially, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 61. This study's planned 126 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2017
First posted
Oct 24, 2017
StartActual
May 2016
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2027
Last update
Feb 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03319758
Responsible party
Baoxin Huang (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Oct 24, 2017
Start date
May 2016
Primary completion
Nov 2026 (estimated)
Completion
Nov 2027 (estimated)
Last update
Feb 9, 2021

Study contacts

Baoxin Huang, PhD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion