Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants

NCT05123898 | Unknown DMC

• 1 other identifier: 09102019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 35 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used collagen matrix "Fibromatrix" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). In the postoperative period the value of soft tissue thickness gain, duration of surgery, severity of pain syndrome and quality of life were assessed. Also, after 3 months simultaneously with installation of gingiva formers biopsy specimens were sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.

Conditions

Soft Tissue Atrophy

Keywords

connective tissue graft; xenogeic collagen matrix; increasing of soft tissue thickness; dental implant; soft tissue augmentation

Outcome Measures

Primary Outcomes (1)

• The amount of soft tissue thickness gain

  To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files will be compared and the vestibular contour changes will be evaluated at 3 equidistant points in the coronary-apical direction.

  Days 90

Secondary Outcomes (12)

• VAS scale

  1 day

• VAS scale

  3 days

• VAS scale

  5 days

• VAS scale

  7 days

• VAS scale

  30 days

Study Arms (2)

1 group

OTHER

The patients underwent implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuber region on the upper jaw.

Procedure: Soft tissue augmentation

2 group

EXPERIMENTAL

The patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibromatrix"

Procedure: Soft tissue augmentation

Interventions

Soft tissue augmentation PROCEDURE

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Ostem dental implant (Osstem Implant Co., Ltd.) 3. Modeling of sterile collagen matrix according to the shape of the recipient bed 4. Fixation of the collagen matrix to the vestibular flap 5. Suturing the wound tightly

1 group; 2 group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of written informed consent of the patient to participate in the study;
• The presence of an included defect (1 teeth) in the distal part of the lower jaw with a sufficient volume of bone tissue;
• Deficiency of soft tissue thickness;
• Adjacent teeth are without any of periodontal disease, namely the absence of periodontal probing depth \> 3 mm in any site of adjacent teeth;
• \. Satisfactory level of oral hygiene, namely full mouth plaque score \< 20% and full mouth bleeding score \< 20%;
• The presence of concomitant pathology in the stage of decompensation;
• Hard smokers (more than 10 cigarettes per day);
• Radio and chemotherapy in history over the past 5 years;
• Pregnancy and breastfeeding;
• Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drug, steroid drugs).

You may not qualify if:

• Patients with infections either periodontally or periapically;
• Pregnantcy following entrance into the study;
• Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
• Subjects, who in the opinion of the investigator, for any reason will not be able to complete the study per protocol.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: January 14, 2020
• Primary Completion: July 28, 2021
• Study Completion: November 20, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)