- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05870774
Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results
Soft Tissue Augmentation Around Implants With Collagen Matrix and Autogenous Graft: 6-months Prospective Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this research was to perform a comparative clinical analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty two patients diagnosed with partial absence of teeth was examined on the basis of the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry of I.M. Sechenov First Moscow State Medical University. Patients had a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the distal parts of the mandible, which was an indication for its increase. All patients were randomly divided into two groups depending on method of soft tissue augmentation used. In 1 group (n=16) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=16) collagen matrix "Fibro-Gide" was used. According to gender and age characteristics, both groups were comparable. Randomization of patients was carried out at the stage of surgical intervention as follows: after a dental implant placement and preparation of recipient's bed, an envelope with a randomly assigned treatment method (using a connective tissue graft or a collagen matrix) was opened.
During the operation, incision was made along the top of the alveolar ridge within the defect; a full-thickness muco-periosteal flap was elevated. Traditional 2-stage dental implantation was performed according to surgical protocols of dental implant systems Astra Tech (Dentsply Implants Manufacturing GmbH, Germany; registration in Russia 27.12.2019 No FSZ 2015/3214). A free connective tissue graft was harvested in patients of the first group. Graft was fixed with a horizontal U-shaped suture to the buccal muco-periosteal flap. In second patients group a fragment of the collagen matrix "Fibro-Gide" was fixed to the buccal muco-periosteal flap (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ - 20207/11765). For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures.
Postoperative recommendations included standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Moscow, Russian Federation, 119991
- I.M. Sechenov First Moscow State Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Non-inclusion criteria:
- 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.
Exclusion Criteria:
- Patients with infections either periodontally or periapically, which developed after inclusion in the study;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: First group
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
|
|
Experimental: Second group
The patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide"
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The amount of soft tissue thickness gain
Time Frame: [Day 90 compared to the 0th day (initial value)]
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The amount of soft tissue thickness gain
Time Frame: [Day 180 compared to the 0th day (initial value)]
|
The value of soft tissue thickness gain in the study area (mm) on the 180th 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 180th 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 180 compared to the 0th day (initial value)]
|
Assessment of the severity of pain syndrome
Time Frame: [Day 1 compared to the 0th day (initial value)].
|
Visual Analogue Scale (VAS).
Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
|
[Day 1 compared to the 0th day (initial value)].
|
Assessment of the severity of pain syndrome
Time Frame: [Day 3 compared to the 0th day (initial value)].
|
Visual Analogue Scale (VAS).
Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
|
[Day 3 compared to the 0th day (initial value)].
|
Assessment of the severity of pain syndrome
Time Frame: [Day 5 compared to the 0th day (initial value)].
|
Visual Analogue Scale (VAS).
Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
|
[Day 5 compared to the 0th day (initial value)].
|
Assessment of the severity of pain syndrome
Time Frame: [Day 7 compared to the 0th day (initial value)]
|
Visual Analogue Scale (VAS).
Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
|
[Day 7 compared to the 0th day (initial value)]
|
Assessment of the severity of pain syndrome
Time Frame: [Day 90 compared to the 0th day (initial value)].
|
Visual Analogue Scale (VAS).
Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
|
[Day 90 compared to the 0th day (initial value)].
|
Assessment of the severity of pain syndrome
Time Frame: [Day 180 compared to the 0th day (initial value)]
|
Visual Analogue Scale (VAS).
Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
|
[Day 180 compared to the 0th day (initial value)]
|
Assessment of the collateral edema
Time Frame: [Day 1 compared to the 0th day (initial value)].
|
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
|
[Day 1 compared to the 0th day (initial value)].
|
Assessment of the collateral edema
Time Frame: [Day 3 compared to the 0th day (initial value)].
|
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
|
[Day 3 compared to the 0th day (initial value)].
|
Assessment of the collateral edema
Time Frame: [Day 5 compared to the 0th day (initial value).]
|
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
|
[Day 5 compared to the 0th day (initial value).]
|
Assessment of the collateral edema
Time Frame: [Day 7 compared to the 0th day (initial value).]
|
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
|
[Day 7 compared to the 0th day (initial value).]
|
Assessment of consumption of analgesics
Time Frame: [Day 1 compared to the 0th day (initial value).]
|
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
|
[Day 1 compared to the 0th day (initial value).]
|
Assessment of consumption of analgesics
Time Frame: [Day 3 compared to the 0th day (initial value).]
|
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
|
[Day 3 compared to the 0th day (initial value).]
|
Assessment of consumption of analgesics
Time Frame: [Day 5 compared to the 0th day (initial value).]
|
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
|
[Day 5 compared to the 0th day (initial value).]
|
Assessment of consumption of analgesics
Time Frame: [Day 7 compared to the 0th day (initial value).]
|
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
|
[Day 7 compared to the 0th day (initial value).]
|
Assessment of the quality of life
Time Frame: [Day 7 compared to the 0th day (initial value).]
|
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions.
Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day.
The OHIP-14 total score can range from 0 to 56.
Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
|
[Day 7 compared to the 0th day (initial value).]
|
Assessment of the quality of life
Time Frame: [Day 90-93 compared to the 0th day (initial value).]
|
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions.
Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day.
The OHIP-14 total score can range from 0 to 56.
Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
|
[Day 90-93 compared to the 0th day (initial value).]
|
Assessment of the quality of life
Time Frame: [Day 180-186 compared to the 0th day (initial value).]
|
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions.
Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day.
The OHIP-14 total score can range from 0 to 56.
Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
|
[Day 180-186 compared to the 0th day (initial value).]
|
Attached mucosa measurement
Time Frame: [Day 0 (initial value)]
|
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe.
This was done by determining the mucosa-gingival junction line on the vestibular side.
The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
|
[Day 0 (initial value)]
|
Attached mucosa measurement
Time Frame: [Day 90-93 compared to the 0th day (initial value)].
|
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe.
This was done by determining the mucosa-gingival junction line on the vestibular side.
The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
|
[Day 90-93 compared to the 0th day (initial value)].
|
Attached mucosa measurement
Time Frame: [Day 180-186 compared to the 0th day (initial value)].
|
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe.
This was done by determining the mucosa-gingival junction line on the vestibular side.
The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
|
[Day 180-186 compared to the 0th day (initial value)].
|
Soft tissue aesthetics
Time Frame: [Day 180-186 compared to the 0th day (initial value) ]
|
Evaluation of soft tissue aesthetics was carried out by visual inspection taking into account the PES (pink aesthetic score).
The evaluation was carried out according to a score of 0-1-2, where 0 was the lowest value and 2 was the highest, the maximum achievable PES value was 14.
|
[Day 180-186 compared to the 0th day (initial value) ]
|
Collaborators and Investigators
Investigators
- Principal Investigator: Igor Ashurko, ass.prof., I.M. Sechenov First Moscow State Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Soft Tissue Atrophy
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingSoft Tissue AtrophyRussian Federation
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingSoft Tissue AtrophyRussian Federation
-
I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingSoft Tissue AtrophyRussian Federation
-
Cairo UniversityUnknownSoft Tissue Atrophy
-
Galderma R&DCompleted
-
University of FlorenceActive, not recruitingEdentulous Alveolar Ridge Atrophy | Soft Tissue Augmentation at Dental ImplantsItaly
-
Istituto Ortopedico RizzoliCompletedSoft Tissue Sarcoma | Soft Tissue Neoplasm | Soft Tissue Mass | Soft Tissue LesionItaly
-
Assiut UniversityNot yet recruitingGingival Recession | Soft Tissue InfectionsEgypt
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
Wake Forest University Health SciencesTerminatedSoft Tissue Sarcoma | Soft Tissue Tumor | Soft Tissue Tumor and/or SarcomaUnited States
Clinical Trials on Soft tissue augmentation with CTG
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingSoft Tissue AtrophyRussian Federation
-
Queen Mary University of LondonGeistlich Pharma AGRecruitingTooth Loss | Wound Heal | Dental DiseasesUnited Kingdom
-
University of Turin, ItalyRecruiting
-
Cairo UniversityCompletedImplant or Graft; RejectionEgypt
-
University of Turin, ItalyRecruiting
-
Akademicka Poliklinika StomatologicznaCamlog Foundation; Wrocław Medical UniversityCompleted
-
Ain Shams UniversityNot yet recruitingSoft Tissue Augmentation | Dental Implants
-
Universidad de MurciaRecruitingImplant Tissue Failure | Peri-Implantitis | Dental Implant FailedSpain
-
I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingSoft Tissue AtrophyRussian Federation
-
Universitat Internacional de CatalunyaOsteology FoundationUnknownTooth Loss | Recession, Gingival