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Increasing the Thickness of Soft Tissues in the Esthetic Zone Around Implants

NCT05551962 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-23

No results posted yet for this study

Summary

This is an interventional prospective randomized clinical trial (RCT) in parallel groups. This study is aimed at detecting a difference in the increase in the thickness of soft tissues of at least 0.3 mm between the two groups (the standard deviation \[SD\] of 0.3 mm and the average value of 1.2 mm was borrowed from an article published by Cairo F et al., 2017). Using SampleSizeCalculator, it was calculated that the number of patients in each group should be 14 (alpha = 0.05; power = 80%). This number was increased by 10%, taking into account possible exceptions from the study. The sample size is 30 patients who will be randomly divided into two groups depending on the surgical intervention used. First group - patients will undergo increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the maxilla or palate. Second group - patients will undergo increasing the thickness of the mucous membrane using collagen matrix "Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ-20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain syndrome, collateral edema, Doppler flowmetry, probing depth, soft tissue aesthetics, keratinized mucosa width and quality of life will be assessed. In addition, after 3 months simultaneously with installation of gingiva formers biopsy specimens will be sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.

Conditions

  • Soft Tissue Atrophy

Interventions

PROCEDURE

Soft tissue augmentation with CTG

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech dental implant (Dentsply, Germany) 3. Sampling of free connective tissue graft from the maxilla tuber area 4. Fixation of the graft to the vestibular flap 5. Suturing the wound tightly

PROCEDURE

Soft tissue augmentation with CM

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech dental implant (Dentsply, Germany) 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

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Igor Ashurko · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2022-12-10
Completion
2023-04-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551962 on ClinicalTrials.gov