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Soft Tissue Management in Peri-Implant Regions

Ö

Ömer Alperen Kırmızıgül

Status

Completed

Conditions

Peri-Implant Tissues
Peri-implant Mucosa Thickness
Peri-implant Mucosa Width

Treatments

Other: Ribose Cross-Linked Thick Collagen Membrane
Other: Connective Tissue Graft

Study type

Interventional

Funder types

Other

Identifiers

NCT06880185
İNU-DHF-ŞMK-01

Details and patient eligibility

About

Background:This study aimed to compare the effect of ribose cross-linked thick collagen membrane (RCCM) with that of subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.

Methods:Single implant sites were included in the study of 20 systemically healthy patients. All procedures were performed concurrently with implant placement; SCTG was administered in ten patients, and RCCM in the other ten. Before the operation, the 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 measurements were repeated.

Results:In terms of PIMT, an average increase of 1.87 mm was recorded in the RCCM group and 1.99 mm in the SCTG group. The rate of increase in PIMT was statistically similar in both the groups (p>0.05). The OHIP-14 and VAS scores were similar between the groups on days 1, 3, and 7. There was a decrease at 3 months in both the groups.

Conclusion:Within the limits of this study, RCCM provided a similar increase in PIMT as SCTG. RCCM is a promising alternative to SCTG for increasing the PIMT.

Keywords: Collagen, Connective tissue, Dental implants, Oral mucosa

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Control
Other group
Description:
Connective Tissue Graft
Treatment:
Other: Connective Tissue Graft
Test
Active Comparator group
Description:
Ribose Cross-Linked Thick Collagen Membrane
Treatment:
Other: Ribose Cross-Linked Thick Collagen Membrane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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