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Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue Defects

ConditionsDental ImplantationPeri-Implant Soft Tissue DeficiencySoft Tissue Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara University

About this trial

Peri-implant soft-tissue defects will be treated with either a volume-stable collagen matrix (VCMX; test group) or an autogenous connective tissue graft (CTG; control group) following implant placement in patients with a single missing tooth. After a mid-crestal incision and full-thickness flap elevation, the graft material will be positioned over the crest beneath the buccal flap and stabilized, followed by tension-free primary closure. Peri-implant soft-tissue thickness, echo intensity, and vascularization will be assessed non-invasively using high-resolution intraoral ultrasonography and Power Doppler imaging. Clinical periodontal parameters and patient-reported outcomes, including pain perception (visual analog scale), swelling, fatigue, analgesic consumption, and wound healing, will be recorded. These outcomes will be evaluated at baseline and on the 1st week, 1st, 3rd, and 6th months. At the 6th month, gingival biopsy samples obtained during healing abutment placement will be evaluated histologically and immunohistochemically (CD11c, CD163, COL1, COL3, MMP-1, TIMP-1) to compare the biological integration of the two graft materials.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >18 years

Periodontal health confirmed according to the 2017 World Workshop criteria (BOP <10%, PD ≤3 mm, absence of gingival inflammation, and good oral hygiene) (Tonetti et al., 2018)

Requirement of implant placement and soft-tissue augmentation for a single missing tooth in the anterior region

Bleeding on probing <30% at the adjacent teeth (Thoma et al., 2016)

Disqualifiers

Siebert Class II or Class III defects

History of surgery at the treated site

Untreated periodontitis or peri-implantitis

Current smoking or smoking within the previous five years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Connective tissue graft

    Procedure/Surgery

    An autogenous connective tissue graft harvested from the palate using the extraoral de-epithelialization technique will be placed over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (control group)

  • Volume-stable collagen matrix

    Device

    A volume-stable porcine-derived collagen matrix (15×20×3 mm) will be trimmed to the defect size, placed over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (test group)

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: VCMX GroupExperimental treatment 1 intervention
Group B: CTG GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

peri-implant soft-tissue thickness

Peri-implant buccal soft-tissue thickness will be measured non-invasively using high-resolution intraoral ultrasonography (LOGIQ P10 XDClear R4.5, GE Healthcare) with an L8-18i-RS high-frequency linear "hockey-stick" probe (8 MHz). Measurements will be repeated preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months. On static B-mode images, linear soft-tissue thickness will be assessed at three levels 1.5, 3, and 5 mm apical to the alveolar crest margin and recorded in millimeters by a single calibrated examiner blinded to group allocation. The primary outcome is the change in linear soft-tissue thickness from baseline to 6 months, compared between the VCMX and CTG groups.

Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months

Secondary outcomes

1

Peri-implant soft-tissue vascularization

Peri-implant soft-tissue perfusion will be evaluated using Power Doppler ultrasonography (PDUS) with the same unit and probe, preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months. Quantitative analysis will use the device's integrated Color Quantification (CQ) module: a circular region of interest (ROI) 6 mm in diameter (area 28.274 mm²), originating from the alveolar crest margin, will be defined. Within this ROI, the proportion of colored (Power Doppler) pixels representing blood flow relative to the total number of pixels will be calculated to obtain a semi-quantitative Power Doppler pixel density . The outcome is the change in pixel density from baseline to 6 months, compared between the VCMX and CTG groups.

Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months
2

Ultrasonographic echo intensity of peri-implant soft tissue

Tissue echogenicity will be evaluated preoperatively (baseline) and postoperatively at 1 week, 1 month, 3 months, and 6 months from static B-mode images obtained with the probe positioned longitudinally over the mid-buccal region of the edentulous site. Echo intensity will be measured in decibels (dB) using the unit's grayscale (echo-intensity) function. The ROI will extend 7 mm apically from the soft-tissue margin. As the device references echo intensity to the system's saturation level, soft-tissue reflections yield negative dB values; less negative values indicate higher echogenicity (denser, more organized tissue), and more negative values indicate hypoechoic/less dense tissue. Measurements will be performed by a single calibrated, blinded examiner, with intra-examiner reliability assessed beforehand. The outcome is the change in echo intensity from baseline to 6 months, compared between the VCMX and CTG groups.

Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months
3

Postoperative pain

Patient-rated pain intensity at 1 week, recorded on a Visual Analog Scale (VAS) anchored at 0 (no pain) and 10 (most severe pain). Compared between the VCMX and CTG groups.

Time frame
1 week
4

Postoperative swelling

Patient-rated swelling at 1 week on a Visual Analog Scale (VAS) from 0 (no swelling) to 10 (most severe). Compared between the VCMX and CTG groups.

Time frame
1 week

Other outcomes

Sponsors and contacts

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Ankara University

Lead sponsor

Source ClinicalTrials.gov
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