Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02864862

Enrollment

Registered

2016-08-12

Start date

2016-10-31

Completion date

2021-11-22

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Immediate Dental Implant, Soft Tissue Augmentation

Brief 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.

Interventions

DEVICEImmediate implant

BIOLOGICALSCTG

BIOLOGICALADM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Ridge Dimension	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.

Secondary

Measure	Time frame	Description
Change in Gingival Thickness	baseline, 6 months after surgery	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.
Change in Width of Keratinized Gingiva	baseline, 6 months after surgery	Change in width of keratinized gingiva is calculated as the value at 6 months minus the value at baseline.
Change in Gingival Level	baseline, 6 months after surgery	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.
Change in Alveolar Bone Level (Crestal)	baseline, 6 months after surgery	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).
Change in Bone Dimension	baseline, 6 months after surgery	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).
Change in Alveolar Bone Level (Marginal)	baseline, 6 months after surgery	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Immediate Implant Combined With SCTG Immediate implant plus Subepithelial connective tissue graft (SCTG)	15
Immediate Implant Combined With ADM Immediate implant plus Acellular dermal matrix (ADM)	15
Immediate Implant Immediate implant alone	16
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	1	0	1
Overall Study	Protocol Violation	0	0	1

Baseline characteristics

Characteristic	Total	Immediate Implant Combined With ADM	Immediate Implant Combined With SCTG	Immediate Implant
Age, Continuous	61.26 years STANDARD_DEVIATION 11.58	63.53 years STANDARD_DEVIATION 13.16	61.53 years STANDARD_DEVIATION 9.81	58.88 years STANDARD_DEVIATION 11.55
Implant diameter 3.5 millimeters (mm)	17 Participants	4 Participants	6 Participants	7 Participants
Implant diameter 4.3mm	28 Participants	11 Participants	8 Participants	9 Participants
Implant diameter 5.0mm	1 Participants	0 Participants	1 Participants	0 Participants
Implant length 10mm	3 Participants	3 Participants	0 Participants	0 Participants
Implant length 11.5mm	15 Participants	7 Participants	4 Participants	4 Participants
Implant length 13mm	21 Participants	5 Participants	8 Participants	8 Participants
Implant length 16mm	7 Participants	0 Participants	3 Participants	4 Participants
Mean number of sites on tooth with bleeding on probing (BOP)	2.50 number of sites STANDARD_DEVIATION 1.66	2.60 number of sites STANDARD_DEVIATION 1.72	2.47 number of sites STANDARD_DEVIATION 1.68	2.44 number of sites STANDARD_DEVIATION 1.59
Mean number of sites on tooth with plaque (PL)	4.32 number of sites STANDARD_DEVIATION 1.78	4.13 number of sites STANDARD_DEVIATION 2.13	4.20 number of sites STANDARD_DEVIATION 1.66	4.63 number of sites STANDARD_DEVIATION 1.54
Mean probing depth(PD) of the tooth	2.26 millimeters STANDARD_DEVIATION 0.43	2.29 millimeters STANDARD_DEVIATION 0.38	2.28 millimeters STANDARD_DEVIATION 0.47	2.24 millimeters STANDARD_DEVIATION 0.45
Number of participants that have diabetes	8 Participants	2 Participants	6 Participants	0 Participants
Number of participants that have hypertension	13 Participants	5 Participants	3 Participants	5 Participants
Number of participants that smoke	5 Participants	0 Participants	1 Participants	4 Participants
Number of participants with anterior implant sites	22 Participants	6 Participants	7 Participants	9 Participants
Number of participants with pre molar implant sites	24 Participants	9 Participants	8 Participants	7 Participants
Peri-implant crestal bone level Distal	3.07 millimeters STANDARD_DEVIATION 1.17	2.88 millimeters STANDARD_DEVIATION 1.13	3.02 millimeters STANDARD_DEVIATION 1.21	3.31 millimeters STANDARD_DEVIATION 1.19
Peri-implant crestal bone level Mesial	3.39 millimeters STANDARD_DEVIATION 1.15	3.01 millimeters STANDARD_DEVIATION 1.08	3.59 millimeters STANDARD_DEVIATION 1.09	3.56 millimeters STANDARD_DEVIATION 1.27
Peri-implant marginal bone level Distal	-0.44 millimeters STANDARD_DEVIATION 1.49	-0.95 millimeters STANDARD_DEVIATION 2.3	-0.03 millimeters STANDARD_DEVIATION 0.1	-0.36 millimeters STANDARD_DEVIATION 1.21
Peri-implant marginal bone level Mesial	-0.169 millimeters STANDARD_DEVIATION 0.55	-0.08 millimeters STANDARD_DEVIATION 0.31	-0.11 millimeters STANDARD_DEVIATION 0.31	-0.31 millimeters STANDARD_DEVIATION 0.83
Postoperative buccal soft tissue thickness	2.02 millimeters STANDARD_DEVIATION 0.31	2.57 millimeters STANDARD_DEVIATION 0.3	2.38 millimeters STANDARD_DEVIATION 0.32	1.18 millimeters STANDARD_DEVIATION 0.31
Preoperative buccal soft tissue thickness	1.25 millimeters STANDARD_DEVIATION 0.27	1.34 millimeters STANDARD_DEVIATION 0.25	1.24 millimeters STANDARD_DEVIATION 0.25	1.18 millimeters STANDARD_DEVIATION 0.31
Race and Ethnicity Not Collected	0 Participants	—	—	—
Region of Enrollment United States	46 Participants	15 Participants	15 Participants	16 Participants
Sex: Female, Male Female	24 Participants	8 Participants	7 Participants	9 Participants
Sex: Female, Male Male	22 Participants	7 Participants	8 Participants	7 Participants
Width of keratinized tissue at baseline	4.67 millimeters STANDARD_DEVIATION 1.22	4.83 millimeters STANDARD_DEVIATION 1.32	4.70 millimeters STANDARD_DEVIATION 1.16	4.50 millimeters STANDARD_DEVIATION 1.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 15	0 / 16
other Total, other adverse events	0 / 15	0 / 15	0 / 16
serious Total, serious adverse events	0 / 15	0 / 15	0 / 16

Outcome results

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.

Time frame: baseline, 12 months after surgery

Population: Data were not collected for 1 participant in the Immediate implant combined with SCTG arm and 2 participants in the Immediate implant arm.

Arm	Measure	Group	Value (MEAN)	Dispersion
Immediate Implant Combined With SCTG	Change in Ridge Dimension	Initial soft tissue margin	-1.80 millimeters (mm)	Standard Deviation 1.52
Immediate Implant Combined With SCTG	Change in Ridge Dimension	1mm below initial soft tissue margin	-1.21 millimeters (mm)	Standard Deviation 0.92
Immediate Implant Combined With SCTG	Change in Ridge Dimension	2mm below initial soft tissue margin	-0.87 millimeters (mm)	Standard Deviation 0.75
Immediate Implant Combined With SCTG	Change in Ridge Dimension	3mm below initial soft tissue margin	-0.48 millimeters (mm)	Standard Deviation 0.63
Immediate Implant Combined With SCTG	Change in Ridge Dimension	4mm below initial soft tissue margin	-0.23 millimeters (mm)	Standard Deviation 0.6
Immediate Implant Combined With SCTG	Change in Ridge Dimension	5mm below initial soft tissue margin	-0.02 millimeters (mm)	Standard Deviation 0.61
Immediate Implant Combined With ADM	Change in Ridge Dimension	5mm below initial soft tissue margin	-0.41 millimeters (mm)	Standard Deviation 0.55
Immediate Implant Combined With ADM	Change in Ridge Dimension	Initial soft tissue margin	-2.33 millimeters (mm)	Standard Deviation 1.15
Immediate Implant Combined With ADM	Change in Ridge Dimension	3mm below initial soft tissue margin	-0.78 millimeters (mm)	Standard Deviation 0.65
Immediate Implant Combined With ADM	Change in Ridge Dimension	4mm below initial soft tissue margin	-0.51 millimeters (mm)	Standard Deviation 0.55
Immediate Implant Combined With ADM	Change in Ridge Dimension	1mm below initial soft tissue margin	-1.61 millimeters (mm)	Standard Deviation 0.95
Immediate Implant Combined With ADM	Change in Ridge Dimension	2mm below initial soft tissue margin	-1.08 millimeters (mm)	Standard Deviation 0.66
Immediate Implant	Change in Ridge Dimension	1mm below initial soft tissue margin	-1.54 millimeters (mm)	Standard Deviation 0.81
Immediate Implant	Change in Ridge Dimension	2mm below initial soft tissue margin	-1.27 millimeters (mm)	Standard Deviation 0.75
Immediate Implant	Change in Ridge Dimension	5mm below initial soft tissue margin	-0.90 millimeters (mm)	Standard Deviation 0.79
Immediate Implant	Change in Ridge Dimension	3mm below initial soft tissue margin	-1.21 millimeters (mm)	Standard Deviation 0.82
Immediate Implant	Change in Ridge Dimension	Initial soft tissue margin	-1.91 millimeters (mm)	Standard Deviation 0.94
Immediate Implant	Change in Ridge Dimension	4mm below initial soft tissue margin	-1.11 millimeters (mm)	Standard Deviation 0.85

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.