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NCT Number: NCT06837688

Enhancing Soft Tissues Around Inserted Implants by Two Different Methods

This randomized controlled clinical trial investigates the efficacy of xenogeneic collagen matrix (XCM) versus autogenous subepithelial connective tissue graft (SCTG) in enhancing the peri-implant soft tissue profile around single dental implants in the aesthetic zone of the anterior maxilla. Thirty adult patients with a single missing tooth, adequate bone volume, and sufficient keratinized tissue will be recruited at Damascus University. Each patient will undergo a fully digital workflow for implant planning-including CBCT imaging, intraoral scanning, and CAD/CAM fabrication of a surgical guide and provisional restoration-to ensure precision in implant placement. Immediately following implant insertion, patients will be randomly allocated (1:1) to either receive a CTG harvested from the palatal mucosa using a single incision technique or an XCM (Mucoderm®, Botiss Biomaterials) that is adapted and secured to the buccal mucosa. The primary outcome is the increase in buccal soft tissue profile, measured via superimposed digital surface models at baseline, immediately postoperatively, and at 3 months. Secondary outcomes include patient-reported measures (pain, edema, aesthetic satisfaction), clinical parameters (keratinized tissue width, soft tissue height), peri-implant health assessments, and radiographic assessment. By comparing these two methods, the study aims to determine whether the less invasive XCM can offer outcomes comparable to the CTG standard while reducing donor site morbidity and overall surgical time.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00000, Syria

Location status: Recruiting

Location contact

Mohammad Younis Hajeer

CONTACT

[email protected]

+963

About this study

This clinical trial is designed to evaluate and compare the performance of two soft tissue augmentation techniques-autogenous subepithelial connective tissue graft (CTG) and xenogeneic collagen matrix (XCM, Mucoderm®)-when used concurrently with dental implant placement in the aesthetic zone of the anterior maxilla. The rationale for this study stems from the clinical challenge of achieving optimal soft tissue esthetics and function following tooth loss. While CTG has long been considered the gold standard for increasing peri-implant soft tissue thickness, it requires a secondary surgical site, which may lead to donor site morbidity, limited tissue availability, and increased surgical time. In contrast, XCM offers a promising alternative that is biocompatible, readily available, and less invasive.

Patients aged 18 years or older with a single missing tooth in the aesthetic zone, adequate bucco-palatal bone (≥6 mm), and at least 5 mm of keratinized tissue width will be considered eligible for the study. The enrollment process begins with a thorough screening process involving clinical and radiographic examinations, including a low-dose, small-field CBCT scan and an intraoral scan. These imaging modalities allow for accurate digital implant planning using specialized software, ensuring optimal implant positioning. The digital data will be used to fabricate a stereolithographic surgical guide and design a custom CAD/CAM screw-retained provisional restoration.

Following successful screening and informed consent, the surgical phase commences. Under local anesthesia, a full-thickness flap is elevated at the implant site. Guided by the digital plan, a dental implant is precisely positioned using the surgical guide. At this point, participants are allocated to one of two intervention groups based on a strict randomization protocol.

In the CTG group, a connective tissue graft is harvested from the palatal mucosa using the de- epithelialized free gingival graft technique. The harvested graft is then trimmed to match the dimensions of the recipient site and carefully positioned under the elevated flap to augment the soft tissue. The donor site is sutured using gelatin matrix to ensure proper healing. This technique, while effective, is associated with postoperative discomfort and additional surgical time due to the need for a second operative site.

Conversely, in the XCM group, soft tissue augmentation is achieved using a xenogeneic collagen matrix (Mucoderm®). The graft, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures. Following soft tissue augmentation, a screw-retained provisional restoration is attached immediately, contributing to both function and esthetics during the healing phase.

The primary outcome of the study is the increase in the buccal soft tissue profile, quantitatively assessed using intraoral scans to generate digital surface models at three critical time points: preoperatively (T0), immediately after surgery (T1), and 3 months postoperatively (T2). Secondary outcomes include clinical assessments-such as probing depth, plaque index, bleeding on probing, keratinized tissue width, graft dimensions, wound closure, surgery time, and complications-as well as radiographic evaluation of marginal bone loss. In addition, patient-reported outcome measures (PROMs), including postoperative pain, swelling, aesthetic satisfaction, and willingness to undergo the same treatment again, will be recorded using validated visual analogue and Likert scales. Aesthetic outcomes, including mid-facial recession, Pink aesthetic score, and mucosal scarring index, will also be documented.

The data will be analyzed on an intention-to-treat basis by an independent statistician. Statistical comparisons between the two groups will help determine whether the xenogeneic collagen matrix offers comparable or superior results to the autogenous connective tissue graft regarding soft tissue volume augmentation, esthetic outcomes, and patient satisfaction. Ethical approval has been obtained from the University of Damascus, and the trial follows the CONSORT guidelines. The results will be disseminated through peer-reviewed publications and presentations at professional conferences, contributing valuable evidence to the field of implant dentistry.

Overall, this study is expected to provide insight into whether XCM can serve as a reliable, less invasive alternative to CTG, thereby potentially enhancing patient outcomes and reducing the complications associated with donor site morbidity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older.
  • Good oral hygiene, defined as full-mouth plaque score ≤25%.
  • Having a single missing tooth in the aesthetic zone of the maxilla.
  • Tooth extraction occurred at least 3 months prior to enrolment.
  • Having adequate bone volume for implant placement (bucco-palatal bone dimension of at least 6 mm).
  • Having at least 5 mm of keratinized tissue width at the implant site.

Exclusion criteria

  • Systemic diseases.
  • Smoking.
  • Periodontal disease.
  • Untreated caries lesions.
  • Need for horizontal bone augmentation at the time of implant placement.

Treatment and study plan

Peri-implant soft tissue augmentation using connective tissue graft

Procedure

A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. A connective tissue graft (CTG) will be harvested from the palatal mucosa using the De-epithelialized free gingival graft technique and tailored to the site dimensions. The graft will be carefully positioned under the elevated flap to augment the soft tissue. The palatal wound will be sutured with double-cross sutures.

Peri-implant soft tissue augmentation using xenogenic collagen matrix

Procedure

A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. The xenogenic collagen matrix, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures.

Primary outcomes

  1. Increase in Buccal Soft Tissue Profile (BSP)

    Time frame: T0: Preoperative baseline. T1: Immediately after surgery. T2: 3 months postoperatively

    he BSP is defined as the volumetric change in the buccal soft tissue at the dental implant site. This outcome reflects both the thickness and contour improvements following soft tissue augmentation. Intraoral scans will be taken at three critical time points: preoperatively (T0), immediately postoperatively (T1), and 3 months postoperatively (T2). Digital surface models will be generated from these scans using specialized analysis software. The increase in BSP will be quantified as the difference in soft tissue volume (or thickness, depending on the analysis protocol) between the baseline (T0) and the 3-month follow-up (T2). Graft shrinkage will be measured between the scans immediately postoperatively (T1) and the 3-month follow-up (T2). his is a continuous variable measured in cubic millimeters (mm³) if volumetric data is used, or in millimeters (mm) if linear thickness is the chosen metric.

Secondary outcomes

  1. Probing Depth (PD)

    Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively

    • Definition: The distance from the gingival margin to the bottom of the peri-implant pocket measured around the implant.
    • Measurement: Using a UNC-15 periodontal probe at six sites around the implant.
    • Type: Continuous variable (measured in millimeters).

  2. Plaque Index (PI)

    Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively.

    • Definition: An ordinal score representing the level of plaque accumulation around the implant.
    • Measurement: Using a standardized modified plaque index (mPI).
    • Type: Ordinal variable.

  3. Bleeding on Probing (BOP)

    Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively

    • Definition: The presence or absence of bleeding upon gentle probing, indicating inflammation.
    • Measurement: Using a standardized modified bleeding index (mBI).
    • Type: Binary at each site, then aggregated.

  4. Graft Dimensions

    Time frame: Recorded intraoperatively.

    • Definition: The length, width, and thickness of the graft as applied.
    • Measurement: Recorded intraoperatively using a UNC-15 periodontal probe.
    • Type: Continuous variables (in millimeters).

  5. Wound Closure

    Time frame: Recorded intraoperatively.

    • Definition: Wound closure is evaluated qualitatively (complete vs. incomplete).
    • Measurement: Wound closure is documented by the surgeon.
    • Type: Wound closure is categorical.

  6. Surgery Time

    Time frame: immediately following surgery

    • Definition: Surgery time is the duration from the initial incision to the final suture placement.
    • Measurement: Surgery time is measured with a stopwatch.
    • Type: Surgery time is a continuous variable (in minutes).

  7. Complications

    Time frame: From intervention to the end of follow-up period at 6 months.

    • Definition: Any adverse events such as infection, dehiscence, graft or implant loss.
    • Measurement: Documented by the surgical team and followed up clinically.
    • Type: Categorical (present/absent, with descriptive details).

  8. Radiographic Evaluation of Marginal Bone Loss

    Time frame: Baseline (immediately postoperative), and 6 months postoperatively.

    • Definition: The change in bone level around the implant measured from the implant shoulder to the first bone-to-implant contact.
    • Measurement: Using CBCT images.
    • Type: Continuous variable (in millimeters).

  9. Postoperative Pain and Swelling

    Time frame: One week postoperatively.

    • Definition: Patient's subjective rating of pain and swelling after surgery.
    • Measurement: Using a visual analogue scale (VAS) ranging from 0 (no pain/swelling) to 10 (worst possible pain/swelling).
    • Type: Ordinal variable.

  10. Aesthetic Satisfaction

    Time frame: 3 months postoperatively.

    • Definition: Patient's satisfaction with the aesthetic outcome of the implant restoration and surrounding soft tissue.
    • Measurement: Using a Likert scale (1-5, where 1 is very dissatisfied and 5 is very satisfied).
    • Type: Ordinal variable.

  11. Willingness to Undergo the Same Treatment Again

    Time frame: 3 months postoperatively.

    • Definition: Patient's acceptance and perceived comfort of the treatment procedure.
    • Measurement: Assessed via a Likert scale (1-5, from not willing to very willing).
    • Type: Ordinal variable.

  12. Mid-Facial Recession

    Time frame: 3 and 6 months postoperatively.

    • Definition: The vertical distance from the incisal edge of the implant-supported crown to the level of the buccal mucosal margin.
    • Measurement: Using a periodontal probe.
    • Type: Continuous variable (in millimeters).

  13. Pink Aesthetic Score (PES)

    Time frame: 3 and 6 months postoperatively.

    • Definition: A composite score evaluating the harmony of the peri-implant soft tissue with adjacent teeth, based on criteria such as mesial/distal papilla, tissue level, contour, and color.
    • Measurement: Using a standardized scoring system (0-14 scale).
    • Type: Ordinal variable.

  14. Mucosal Scarring Index (MSI)

    Time frame: 3 and 6 months postoperatively.

    • Definition: A measure of the presence and severity of scar formation at the graft site, based on criteria like color, contour, texture, and vascularity.
    • Measurement: Assessed using a categorical scoring system.
    • Type: Categorical variable.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Omair, DDS

CONTACT

[email protected]

+963992964458

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of Xenogeneic Collagen Matrix Versus Connective Tissue Graft to Enhance Soft Tissue Profile Around Single Dental Implants in the Aesthetic Zone

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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