Jaw, Edentulous, PartiallyNCT03319758
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
A study testing buccal bone augmentation in people with Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, run by Sun Yat-sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
- What is being tested?
- buccal bone augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
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.
- Being tested
- buccal bone augmentation
- Keywords
- bone augmentation, esthetics, immediate implant, buccal bone defects
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal bone augmentationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: buccal bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 years after baseline
Secondary outcomes (10)
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.
Measured: Change from baseline up to 10 years after implantation
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
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startMay 2016
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoxin Huang, Sun Yat-sen University
- Investigators
- Baoxin Huang, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319758
- Sponsor's protocol ID
- Baoxin Huang
- Status last verified
- Feb 2021
- First submitted
- 14 Sep 2017
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 25916859Barone 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 24684275Aloy-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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
- ClinicalTrials.gov ID
- NCT03319758
- Acronym / sponsor ID
- Baoxin Huang
- Keywords
- bone augmentation, esthetics, immediate implant, buccal bone defects
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thin or dehiscences buccal plate | Experimental | Procedure: buccal bone augmentationImmediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buccal bone augmentationSubjects 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. | Procedure or surgery | thin or dehiscences buccal plate |
Primary outcome
Radiographic bone volume
Time frame: Up to 10 years after baseline
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.
10 secondary outcomes
Change of Pink and white esthetic scores (PES/WES)
Time frame: Change from baseline up to 10 years after implantation
Visual analogue scale (VAS)
Time frame: Up to 10 years after baseline
Oral health impact profile shortened version (OHIP-I)
Time frame: Up to 10 years after baseline
Buccal marginal recession
Time frame: Up to 10 years after baseline
Papilla volume
Time frame: Up to 10 years after baseline
Width of keratinized gingiva
Time frame: Up to 10 years after baseline
Implant survival
Time frame: Up to 10 years after baseline
Probing depth
Time frame: Up to 10 years after baseline
Modified plaque index
Time frame: Up to 10 years after baseline
Modified bleeding index
Time frame: Up to 10 years after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Results publication: PubMed 25916859Sarnachiaro 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.
- Results publication: PubMed 24684275Barone 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.
- Results publication: PubMed 26330931Aloy-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baoxin Huang, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing buccal bone augmentation in people with Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic bone volume (time frame: Up to 10 years after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319758, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.