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

NCT05551962 | Unknown

• 1 other identifier: 10012022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

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

  The value of the increase in the thickness of soft tissues in the study area (mm) on the 90th day compared to the 0th day (initial value).To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № РД-27221/26851) 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.

  Day 90 compared to the 0th day (initial value)

Secondary Outcomes (17)

• Assessment of the severity of pain syndrome

  Day 1 compared to the 0th day (initial value)

• Assessment of the severity of pain syndrome

  Day 3 compared to the 0th day (initial value)

• Assessment of the severity of pain syndrome

  Day 5 compared to the 0th day (initial value)

• Assessment of the collateral edema

  Day 3 compared to the 0th day (initial value)

• Assessment of the collateral edema

  Day 5 compared to the 0th day (initial value)

Study Arms (2)

First group

ACTIVE COMPARATOR

The patients undergo 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 maxilla or palate.

Procedure: Soft tissue augmentation with CTG

Second group

EXPERIMENTAL

The patients undergo implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide"

Procedure: Soft tissue augmentation with CM

Interventions

Soft tissue augmentation with CTG PROCEDURE

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

First group

Soft tissue augmentation with CM PROCEDURE

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

Second group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The presence of written informed consent of the patient to participate in the study;
• Age from 18 to 45 years;
• The presence of an included defect in the esthetic zone part of maxilla with a sufficient volume of bone tissue;
• Soft tissue thickness \<3 mm on the vestibular side;
• Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow;
• Satisfactory level of oral hygiene;
• Patients without concomitant pathology or with concomitant pathology in the compensation stage.
• Age less than 18 and more than 45 years;
• Heavy smokers (more than 10 cigarettes a day);
• Patients with somatic diseases in the stage of decompensation or in the stage of exacerbation;
• Patients with malignant tumors, as well as patients with a history of radiation and chemotherapy over the past 5 years;
• Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drugs, steroid drugs);
• Pregnancy and breastfeeding;
• Patients with mental disorders.

You may not qualify if:

• Pregnancy following entrance into the study;
• Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
• Patients who, for one reason or another, could not complete the entire protocol to the end.

Sponsors & Collaborators

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

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

RECRUITING

Study Officials

• Igor Ashurko

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Ashurko

CONTACT

+7-926-515-05-55; ashurko_i_p@staff.sechenov.ru

Daria Krylova

CONTACT

+7-916-017-24-70; saveleva_d_a@student.sechenov.ru

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: September 20, 2022
• First Posted: September 23, 2022
• Study Start: June 9, 2022
• Primary Completion: December 10, 2022
• Study Completion: April 15, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)