Enhancing Soft Tissues Around Inserted Implants by Two Different Methods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Missing Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

After screening and obtaining informed consent, patients are randomly allocated into one of the two intervention groups (CTG or XCM) in a 1:1 ratio using a permuted block randomization method with block sizes of 4 and 6. The allocation sequence, generated by an independent statistician, is secured in sequentially numbered, opaque envelopes and is revealed at the time of surgery to assign the appropriate intervention. Our study is designed as a single-blinded trial. The outcome assessors and data analysts will be blinded to treatment allocation.

Study Groups

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Connective tissue graft group

Patients receive soft tissue augmentation using an autogenous connective tissue graft. A full-thickness flap is elevated at the implant site, and after implant placement, a CTG is harvested from the palatal mucosa. The graft is then trimmed to the defect dimensions and positioned under the flap to augment the peri-implant soft tissue. The donor site is sutured with double-cross sutures to ensure proper healing

Group Type ACTIVE_COMPARATOR

Peri-implant soft tissue augmentation using connective tissue graft

Intervention Type 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.

Xenogeneic collagen matrix group

Patients receive soft tissue augmentation using a xenogeneic collagen matrix (Mucoderm®). After implant placement and flap elevation, the XCM, initially sized at 15 × 20 mm, is moistened in saline for 10 minutes and slightly compressed. It is then adapted to the recipient site following a superficial incision to release muscle tension and secured to the buccal mucosa with single sutures. A screw-retained provisional restoration is installed immediately after surgery to support the augmented tissue.

Group Type EXPERIMENTAL

Peri-implant soft tissue augmentation using xenogenic collagen matrix

Intervention Type 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.

Interventions

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Peri-implant soft tissue augmentation using connective tissue graft

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.

Intervention Type PROCEDURE

Peri-implant soft tissue augmentation using xenogenic collagen matrix

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes