Dental ImplantPhase 4NCT02864862
Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
A Phase 4 study testing Immediate implant, SCTG and ADM in people with Dental Implant and Immediate Dental Implant, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Immediate Dental Implant, Soft Tissue Augmentation
- What is being tested?
- Immediate implant, SCTG and ADM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 22 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are in need of a tooth extraction at the maxillary premolar, canine and incisor region, and subsequent single implant placement.
- The reasons for extraction will include poor endodontic prognosis and/or unrestorable teeth (extensive caries, traumatic fractures, fractures of endodontically treated teeth, root perforation, root resorption with or without radiographic periapical lesion up to 3 mm in diameter). patients who are systemically healthy or with controlled common systemic conditions (controlled hypertension, controlled diabetes HbA1c up to 7 %).
- adjacent teeth have to be present and the eligible tooth has esthetically acceptable buccal gingival margin position prior to surgery, compared to neighboring teeth and contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).
- level of radiographic bone level has the distance from CEJ to interproximal crest up to 4 mm.
- Location of buccal alveolar crest has to be generally within 4 mm from the free gingival margin, verified after the extraction, before randomization; and fenestration, if present, up to 3mm in diameter at the apical part of the root and affecting less than 30% of the buccal socket wall.
Who cannot join
- currently smoke exceeding 10 cigarettes/ day
- severe parafunctional habits, malocclusion or intent of orthodontic therapy in the future and are pregnant.
- teeth in the surgical site will be excluded if there is advanced periodontal disease or periapical lesion causing significant bony defects that are beyond the criteria mentioned at Section 3.3.
- allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin, polymixin B and Vancomycin) will not be included in the immediate implant combined with ADM group.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone.
- Being tested
- Immediate implant, SCTG, ADM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implantDevice
SCTGBiological
ADMBiological
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant | Active comparator | Immediate implant alone Receives: Device: Immediate implant |
| Immediate implant combined with SCTG | Active comparator | Subepithelial connective tissue graft (SCTG) Receives: Device: Immediate implant; Biological: SCTG |
| Immediate implant combined with ADM | Active comparator | Acellular dermal matrix (ADM) Receives: Device: Immediate implant; Biological: ADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ridge Dimension
Change in ridge dimension is calculated as the value at 6 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 6 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.
Measured: baseline, 6 months after surgery
Change in Ridge Dimension
Change in ridge dimension is calculated as the value at 12 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 12 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.
Measured: baseline, 12 months after surgery
Secondary outcomes (6)
Change in Gingival Level
Change in gingival level is calculated as the value at 6 months minus the value at baseline. Gingival level is measured at three sites: mesial, mid-buccal and distal sites. Gingival level is measured from a notch on a custom fabricated stent to the mucosal margin.
Measured: baseline, 6 months after surgery
Change in Gingival Thickness
Change in gingival thickness is calculated as the value at 6 months minus the value at baseline. Gingival thickness is measured using a stoppered endodontic file (#30) penetrating through the facial soft tissue 3 millimeters (mm) below the mid-buccal peri-implant mucosal margin.
Measured: baseline, 6 months after surgery
Change in Width of Keratinized Gingiva
Change in width of keratinized gingiva is calculated as the value at 6 months minus the value at baseline.
Measured: baseline, 6 months after surgery
Change in Alveolar Bone Level (Marginal)
Change in alveolar bone level is calculated as the value at 6 months minus the value at baseline. The bone level measurement, taken from the standardized periapical radiographs, was defined as the distance from the first bone to implant contact (IB) at either the mesial or the distal aspect of the implant to the implant platform. Specifically, marginal bone level was defined as the distance between the vertical implant bone level (IB; the first bone to implant contact) and implant platform (IP). Crestal bone level was defined as the distance between the interproximal crestal bone level (IC) and implant platform (IP).
Measured: baseline, 6 months after surgery
Change in Alveolar Bone Level (Crestal)
Change in alveolar bone level is calculated as the value at 6 months minus the value at baseline. The bone level measurement, taken from the standardized periapical radiographs, was defined as the distance from the first bone to implant contact (IB) at either the mesial or the distal aspect of the implant to the implant platform. Specifically, crestal bone level was defined as the distance between the interproximal crestal bone level (IC) and implant platform (IP).
Measured: baseline, 6 months after surgery
Change in Bone Dimension
Change in bone dimension is calculated as the value at 6 months minus the value at baseline. To measure bone dimensions, bone dimensions on cone beam computed tomography (CBCT) images were assessed using software. Bone dimension was assessed at the initial buccal crestal bone level (and at 1mm increments below).
Measured: baseline, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startOct 2016
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Teh Lee, The University of Texas Health Science Center, Houston
- Investigators
- Chun-Teh Lee, DDS, DMSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864862
- Sponsor's protocol ID
- HSC-DB-16-0286
- Status last verified
- Nov 2022
- First submitted
- 9 Aug 2016
- Last updated
- 16 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jung M, Tran D, Chang CC, Kim SK, Tsukiboshi Y, Min S, Ayilavarapu S, Lee CT. Volumetric buccal bone alterations at immediate implant sites with or without soft tissue augmentation: A 6-month assessment. J Periodontol. 2026 Feb;97(2):220-233. doi: 10.1002/jper.11381. Epub 2025 Aug 10.
PubMed 40785129
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
- ClinicalTrials.gov ID
- NCT02864862
- Acronym / sponsor ID
- HSC-DB-16-0286
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 16 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate implant | Active comparator | Device: Immediate implantImmediate implant alone |
| Immediate implant combined with SCTG | Active comparator | Device: Immediate implant, Biological: SCTGSubepithelial connective tissue graft (SCTG) |
| Immediate implant combined with ADM | Active comparator | Device: Immediate implant, Biological: ADMAcellular dermal matrix (ADM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients who are in need of a tooth extraction at the maxillary premolar, canine and incisor region, and subsequent single implant placement.
- The reasons for extraction will include poor endodontic prognosis and/or unrestorable teeth (extensive caries, traumatic fractures, fractures of endodontically treated teeth, root perforation, root resorption with or without radiographic periapical lesion up to 3 mm in diameter). patients who are systemically healthy or with controlled common systemic conditions (controlled hypertension, controlled diabetes HbA1c up to 7 %).
- adjacent teeth have to be present and the eligible tooth has esthetically acceptable buccal gingival margin position prior to surgery, compared to neighboring teeth and contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).
- level of radiographic bone level has the distance from CEJ to interproximal crest up to 4 mm.
- Location of buccal alveolar crest has to be generally within 4 mm from the free gingival margin, verified after the extraction, before randomization; and fenestration, if present, up to 3mm in diameter at the apical part of the root and affecting less than 30% of the buccal socket wall.
Key exclusion criteria (4 listed)
- currently smoke exceeding 10 cigarettes/ day
- severe parafunctional habits, malocclusion or intent of orthodontic therapy in the future and are pregnant.
- teeth in the surgical site will be excluded if there is advanced periodontal disease or periapical lesion causing significant bony defects that are beyond the criteria mentioned at Section 3.3.
- allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin, polymixin B and Vancomycin) will not be included in the immediate implant combined with ADM group.
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 |
|---|---|---|
| Immediate implant | Device | Immediate implant, Immediate implant combined with ADM, Immediate implant combined with SCTG |
| SCTG | Biological | Immediate implant combined with SCTG |
| ADM | Biological | Immediate implant combined with ADM |
Primary outcome
Change in Ridge Dimension
Time frame: baseline, 6 months after surgery
Change in ridge dimension is calculated as the value at 6 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 6 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.
Change in Ridge Dimension
Time frame: baseline, 12 months after surgery
Change in ridge dimension is calculated as the value at 12 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 12 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.
6 secondary outcomes
Change in Gingival Level
Time frame: baseline, 6 months after surgery
Change in Gingival Thickness
Time frame: baseline, 6 months after surgery
Change in Width of Keratinized Gingiva
Time frame: baseline, 6 months after surgery
Change in Alveolar Bone Level (Marginal)
Time frame: baseline, 6 months after surgery
Change in Alveolar Bone Level (Crestal)
Time frame: baseline, 6 months after surgery
Change in Bone Dimension
Time frame: baseline, 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40785129Jung M, Tran D, Chang CC, Kim SK, Tsukiboshi Y, Min S, Ayilavarapu S, Lee CT. Volumetric buccal bone alterations at immediate implant sites with or without soft tissue augmentation: A 6-month assessment. J Periodontol. 2026 Feb;97(2):220-233. doi: 10.1002/jper.11381. Epub 2025 Aug 10.
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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.
Chun-Teh Lee, DDS, DMSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate implant, SCTG and ADM in people with Dental Implant and Immediate Dental Implant, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 16 Dec 2022. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Ridge Dimension (time frame: baseline, 6 months after surgery). The study lists 2 primary outcomes in all. 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 NCT02864862, which also lists 1 linked publication.
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 16 Dec 2022.