Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation

NCT05330702 | Terminated Results DMC FDA Device

• 1 other identifier: 202203162
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Mid-facial recession following immediate implant placement (IIP) in the place of a tooth poses a significant challenge for clinicians to treat. Emerging evidence shows that connective tissue graft (CTG) augmentation may mitigate the remodeling of the buccal bone crest (i.e., bone within the gum that supports the tooth), and lessen the soft tissue recession. A recent systemic review suggested a supplemental CTG grafting to IIP as a standard of care, especially for cases that have a high esthetic risk, specifically with a thin gingival biotype (i.e., thin gum tissue) and a thin buccal bone plate. The alternative option to augment the facial contour is the xenogeneic volume-stable collagen matrix (VCMX), which favors avoiding morbidity but hasn't been thoroughly investigated on IIP. Despite that IIP has attracted considerable scientific interest, the dynamic changes of the bone crest and soft tissue, especially during the early healing stage (\<3 months following IIP), are little known. Recently, an ultrasonography protocol has been validated for its diagnostic value in dental implant research. High-frequency B-mode imaging and color flow and power Doppler are implemented to display the spatial relation of anatomic landmarks of peri-implant tissues and to visualize the flow velocity and blood volume, respectively. It provides a valuable real-time diagnostic tool to evaluate hard and soft tissue remodeling and tissue perfusion changes during the early healing stage around IIP, comparing CTG and VCMX grafting. Hence, the purpose of this three-arm RCT is to compare the clinical efficacy and longitudinal remodeling of hard and soft tissue around IIP among CTG, VCMX, and control (without soft tissue augmentation) group. This will be the first evidence of the longitudinal tissue changes around immediate implant, and the first RCT comparing the clinical efficacy and esthetic outcome of xenogenic soft tissue substitute (i.e., from the non-living bone of another species) to the gold standard approach (CTG) on the immediate implants.

Conditions

Tooth Extraction; Immediate Implant Placement

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants That Had an Implant That Survived 6 Months After Immediate Implant Placement Either With or Without Soft Tissue Grafting

  For participants that had immediate implant placement either with or without soft tissue grafting, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 6 months. Note: Only 1 implant was placed per participant.

  6 months after immediate implant placement

Study Arms (3)

Tuberosity Connective Tissue Graft (CTG)

EXPERIMENTAL

Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.

Procedure: Tuberosity Connective Tissue Graft (CTG)

Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft

EXPERIMENTAL

Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.

Device: Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation

No Soft Tissue Augmentation

NO INTERVENTION

Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.

Interventions

Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation DEVICE

Fibro-gide is the VCMX

Also known as: Fibro-Gide, Geistlich Pharma

Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft

Tuberosity Connective Tissue Graft (CTG) PROCEDURE

CTG will be taken from the patient's own mouth

Tuberosity Connective Tissue Graft (CTG)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-95
• Has a single hopeless tooth in the maxillary esthetic zone (i.e., first premolar to first premolar, tooth #5-tooth #13)
• Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque score (FMPS) of less than 25%)
• Adequate tooth space to support an immediate implant placement (i.e., adequate mesiodistal space of greater than or equal to 6 mm and interocclusal space to support a non-occluding provisionalization).
• Postextraction vertical bone defect of the buccal socket wall was less than or equal to 3mm.

You may not qualify if:

• patients taking long-term (more than 3 months) medications affecting bone metabolism
• generalized untreated periodontitis with greater than of 30% of sites with greater than 5mm pocket depths and bleeding upon probing with a dental probe
• medical contraindications for having a surgical procedure (i.e., ASA Status of III, patient with a severe systemic disease that is not life-threatening; ASA Status of IV, a patient with a severe systemic disease that is a constant threat to life).
• history of radiotherapy in the head and neck region
• heavy smoker (greater than 10 cigarettes per day)
• pregnancy
• gingival recession before extraction in relation to the contralateral tooth.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

Results Point of Contact

• Title: Shaoping Zhang
• Organization: University of Iowa

shaoping-zhang@uiowa.edu

(319) 335-7386

Study Officials

• Shaoping Zhang, DDS, MS, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: January 17, 2023
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)