Clinical trial NCT06880185: EVALUATİON OF THE EFFECTS OF RİBOSE CROSS-LİNKED THİCK COLLAGEN MEMBRANES WİTH CONNECTİVE TİSSUE GRAFTS ON SOFT TİSSUE AND POST-OPERATİVE PATİENT COMFORT İN AREAS WİTH PERİ-IMPLANT SOFT TİSSUE DEFECTS
Official title: EVALUATİON OF THE EFFECTS OF RİBOSE CROSS-LİNKED THİCK COLLAGEN MEMBRANES WİTH CONNECTİVE TİSSUE GRAFTS ON SOFT TİSSUE AND POST-OPERATİVE PATİENT COMFORT İN AREAS WİTH PERİ-IMPLANT SOFT TİSSUE DEFECTS: A RANDOMİZED CONTROLLED CLİNİCAL TRİAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucosa Thickness
Peri-implant Mucosa Width
Peri-Implant Tissues
Keywords: Collagen membranes
Soft tissue
Peri-implant mucosa thickness
Peri-implant mucosa width
Connective tissue graft
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2025-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim:Methods to increase peri-implant mucosa thickness (PIMT) in cases of soft tissue deficiency are important to maintain peri-implant health and aesthetics. The aim of this study was to compare the effect of ribose cross-linked thick collagen membrane (RCCM) compared to subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.

Materials and Methods:In our study, single implant sites in 20 systemically healthy patients were included. 10 patients were operated simultaneously with the implant operation and 10 patients were operated simultaneously with the implant operation. Before the operation, PIMT and peri-implant mucosa width (PIMW) were measured. Visual analog scale (VAS) and oral health impact profile-14 (OHIP-14) scores were recorded on post operative days 1, 3 and 7. At 1 and 3 months, VAS and OHIP-14 measurements were repeated.

Keywords:Connective tissue graft, Collagen membrane, Soft tissue, Peri-implant mucosa thickness, Peri-implant mucosa width.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy
* The edentulous space for which implant treatment is planned to be single tooth size and molar tooth site
* Those with soft tissue deficiency in the horizontal aspect in the site where implant treatment is planned
* Age between 18-60 years
* Does not have a condition that may cause a bleeding disorder
* No nausea-vomiting reflex
* Patients with good oral hygiene

Exclusion Criteria:

* Patients with systemic disorders (diabetes, hypertension, radiotherapy/ chemotherapy, etc.)
* Patients who have insufficient horizontal alveolar bone in the site where implant treatment is planned and who may lead to bone dehiscence after implant placement
* Patients with collagen allergy
* Those taking any medication that may affect wound healing
* Those with bleeding disorders
* Smokers who smoke more than 10 cigarettes a day
* Poor oral hygiene
* Those with vomiting-nausea reflex
* Allergic to anti-inflammatory drugs
* Patients with pregnancy/breastfeeding status.

Primary outcomes:
measure: Peri-implant Mucosa Thickness
timeFrame: From the beginning to the 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu Unıversity Faculty of Dentistry
Study officials:
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