NCT05870774

Brief Summary

This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 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 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, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

September 26, 2025

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

April 25, 2023

Last Update Submit

September 23, 2025

Conditions

Soft Tissue Atrophy

Keywords

Connective tissue graftxenogeic collagen matrixincreasing of soft tissue thicknessdental implantsoft tissue augmentation

Outcome Measures

Primary Outcomes (1)

  • The amount of soft tissue thickness gain

    The value of soft tissue thickness gain in the study area (mm) on the 90th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).

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

Secondary Outcomes (23)

  • The amount of soft tissue thickness gain

    [Day 180 compared to the 0th day (initial value)]

  • 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 severity of pain syndrome

    [Day 7 compared to the 0th day (initial value)]

  • +18 more secondary outcomes

Study Arms (2)

First group

ACTIVE COMPARATOR

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

Procedure: Soft tissue augmentation with CTG

Second group

EXPERIMENTAL

The patients underwent 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 CTGPROCEDURE

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

First group
Soft tissue augmentation with CMPROCEDURE

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 mucosal-periosteal flap 5. Suturing the wound tightly

Second group

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The presence of written informed consent of the patient to participate in the study;
  • Age from 25 to 59 years;
  • The presence of an included defect in the distal part of the lower jaw 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 25 and more than 59 years;
  • Hard smokers (more than 10 cigarettes a day);
  • The presence of concomitant pathology in the stage of decompensation;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

Related Publications (1)

  • Ashurko I, Tarasenko S, Magdalyanova M, Balyasin M, Galyas A, Kazumyan S, Safi N, Unkovskiy A. 3D-Analysis of Peri-Implant Soft Tissue Gain With Collagen Matrix and Connective Tissue Graft: A Randomized Control Trial. Clin Implant Dent Relat Res. 2025 Apr;27(2):e70043. doi: 10.1111/cid.70043.

    PMID: 40254798DERIVED

Study Officials

  • Igor Ashurko, ass.prof.

    I.M. Sechenov First Moscow State Medical University

    PRINCIPAL INVESTIGATOR

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

April 25, 2023

First Posted

May 23, 2023

Study Start

October 28, 2021

Primary Completion

December 25, 2022

Study Completion

May 18, 2023

Last Updated

September 26, 2025

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)