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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant | Active Comparator | Immediate implant alone |
|
| Immediate implant combined with SCTG | Active Comparator | Subepithelial connective tissue graft (SCTG) |
|
| Immediate implant combined with ADM | Active Comparator | Acellular dermal matrix (ADM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate implant | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline, 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-Teh Lee, DDS, DMSc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40785129 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Implant Combined With SCTG | Immediate implant plus Subepithelial connective tissue graft (SCTG) |
| FG001 | Immediate Implant Combined With ADM | Immediate implant plus Acellular dermal matrix (ADM) |
| FG002 | Immediate Implant | Immediate implant alone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Implant Combined With SCTG | Immediate implant plus Subepithelial connective tissue graft (SCTG) |
| BG001 | Immediate Implant Combined With ADM | Immediate implant plus Acellular dermal matrix (ADM) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Implant Combined With SCTG | Immediate implant plus Subepithelial connective tissue graft (SCTG) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chun-Teh Lee | The University of Texas Health Science Center at Houston | 713-486-4384 | Chun-Teh.Lee@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2016 | Nov 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| SCTG |
| Biological |
|
| ADM | Biological |
|
| 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. |
| 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. | 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). | 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). | 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). | baseline, 6 months after surgery |
| BG002 | Immediate Implant | Immediate implant alone |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of participants that smoke | Count of Participants | Participants |
|
| Number of participants that have diabetes | Count of Participants | Participants |
|
| Number of participants that have hypertension | Count of Participants | Participants |
|
| Number of participants with anterior implant sites | Count of Participants | Participants |
|
| Number of participants with pre molar implant sites | Count of Participants | Participants |
|
| Implant diameter | Count of Participants | Participants |
|
| Implant length | Count of Participants | Participants |
|
| Mean probing depth(PD) of the tooth | Mean | Standard Deviation | millimeters |
|
| Mean number of sites on tooth with bleeding on probing (BOP) | Mean | Standard Deviation | number of sites |
|
| Mean number of sites on tooth with plaque (PL) | Mean | Standard Deviation | number of sites |
|
| Width of keratinized tissue at baseline | Mean | Standard Deviation | millimeters |
|
| Preoperative buccal soft tissue thickness | Mean | Standard Deviation | millimeters |
|
| Postoperative buccal soft tissue thickness | Mean | Standard Deviation | millimeters |
|
| Peri-implant marginal bone level | Mean | Standard Deviation | millimeters |
|
| Peri-implant crestal bone level | Mean | Standard Deviation | millimeters |
|
Immediate implant plus Acellular dermal matrix (ADM) |
| OG002 | Immediate Implant | Immediate implant alone |
|
|
| Primary | 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. | Data were not collected for 1 participant in the Immediate implant combined with SCTG arm and 2 participants in the Immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 12 months after surgery |
|
|
|
| Secondary | 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. | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
|
|
| Secondary | 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. | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
|
|
| Secondary | 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. | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
|
|
| Secondary | 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). | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
|
|
| Secondary | 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). | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
|
|
| Secondary | 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). | Data were not collected for one participant in the immediate implant arm. | Posted | Mean | Standard Deviation | millimeters (mm) | baseline, 6 months after surgery |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Immediate Implant Combined With ADM | Immediate implant plus Acellular dermal matrix (ADM) | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Immediate Implant | Immediate implant alone | 0 | 16 | 0 | 16 | 0 | 16 |
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| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |
| Male |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
|
| 2mm below initial soft tissue margin |
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| 3mm below initial soft tissue margin |
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| 4mm below initial soft tissue margin |
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| 5mm below initial soft tissue margin |
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| Distal |
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| 2mm below initial crestal bone level |
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| 3mm below initial crestal bone level |
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| 4mm below initial crestal bone level |
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| 5mm below initial crestal bone level |
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| 6mm below initial crestal bone level |
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| 7mm below initial crestal bone level |
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| 8mm below initial crestal bone level |
|
| 9mm below initial crestal bone level |
|
| Coronal third |
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| Middle third |
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| Apical third |
|