Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
29 mei 2026 bijgewerkt door: I.M. Sechenov First Moscow State Medical University
Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned.
The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed.
In the first group, a free connective tissue graft with an epithelial collar will be used.
In the second group, a free connective tissue graft without an epithelial collar will be used.
In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Gedetailleerde beschrijving
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
32
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Moscow, Rusland
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
- Written informed consent for participation in the study;
- Age between 18 and 45 years;
- Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
- Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
- Satisfactory level of oral hygiene;
- Absence of systemic diseases in the stage of exacerbation or decompensation.
Non-inclusion criteria:
- Patients who previously underwent connective tissue graft harvesting from the same donor site;
- Patients with impacted third molars in the donor site area;
- Presence of concomitant diseases in the stage of exacerbation or decompensation;
- Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
- Patients with a smoking history of more than 10 years.
Exclusion Criteria:
- Patient refusal to continue participation in the study;
- Pregnant or breastfeeding women;
- Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: first group
Patients will receive a free connective tissue graft without an epithelial collar
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Experimenteel: second group
Patients will receive a free connective tissue graft with epithelial collar
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in the Width of Keratinized Mucosa
Tijdsspanne: Day 90 compared to the 0th day (initial value)
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Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
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Day 90 compared to the 0th day (initial value)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in the Width of Keratinized Mucosa
Tijdsspanne: Day 180 compared to the 0th day (initial value)
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Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
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Day 180 compared to the 0th day (initial value)
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Assessment of Scar Formation According to the Modified Scar Index (MSI)
Tijdsspanne: Day 90 compared to the 0th day (initial value)
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Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
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Day 90 compared to the 0th day (initial value)
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Assessment of Scar Formation According to the Modified Scar Index (MSI)
Tijdsspanne: Day 180 compared to the 0th day (initial value)
|
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
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Day 180 compared to the 0th day (initial value)
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Assessment of Pain Severity
Tijdsspanne: 4 hours compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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4 hours compared to the 0th day (initial value)
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Assessment of Pain Severity
Tijdsspanne: Day 1 compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 1 compared to the 0th day (initial value)
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Assessment of Pain Severity
Tijdsspanne: Day 3 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 3 compared to the 0th day (initial value)
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Assessment of Pain Severity
Tijdsspanne: Day 5 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 5 compared to the 0th day (initial value)
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Assessment of Pain Severity
Tijdsspanne: Day 7 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 7 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
Tijdsspanne: Day 1 compared to the 0th day (initial value)
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Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
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Day 1 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
Tijdsspanne: Day 3 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 3 compared to the 0th day (initial value)
|
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Assessment of Postoperative Swelling Severity
Tijdsspanne: Day 5 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 5 compared to the 0th day (initial value)
|
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Assessment of Postoperative Swelling Severity
Tijdsspanne: Day 7 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
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Day 7 compared to the 0th day (initial value)
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Assessment of Bleeding
Tijdsspanne: Day 1 compared to the 0th day (initial value)
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Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
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Day 1 compared to the 0th day (initial value)
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Assessment of Bleeding
Tijdsspanne: Day 3 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 3 compared to the 0th day (initial value)
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Assessment of Bleeding
Tijdsspanne: Day 5 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 5 compared to the 0th day (initial value)
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Assessment of Bleeding
Tijdsspanne: Day 7 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 7 compared to the 0th day (initial value)
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Assessment of Analgesic Intake
Tijdsspanne: Day 1 compared to the 0th day (initial value)
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Assessment of the number of Nimesulide 100 mg tablets taken per day.
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Day 1 compared to the 0th day (initial value)
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Assessment of Analgesic Intake
Tijdsspanne: Day 3 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Tijdsspanne: Day 5 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Tijdsspanne: Day 7 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 7 compared to the 0th day (initial value)
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Quality of Life Assessment According to OHIP-14
Tijdsspanne: Day 0 (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 0 (initial value)
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Quality of Life Assessment According to OHIP-14
Tijdsspanne: Day 7 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 7 compared to the 0th day (initial value)
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Quality of Life Assessment According to OHIP-14
Tijdsspanne: Day 90-93 compared to the 0th day (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 90-93 compared to the 0th day (initial value)
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Quality of Life Assessment According to OHIP-14
Tijdsspanne: Day 180-186 compared to the 0th day (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 180-186 compared to the 0th day (initial value)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Igor P Ashurko, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 juni 2024
Primaire voltooiing (Geschat)
20 juni 2026
Studie voltooiing (Geschat)
20 augustus 2026
Studieregistratiedata
Eerst ingediend
29 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 mei 2026
Eerst geplaatst (Werkelijk)
4 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
29 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- AI-05
Plan Individuele Deelnemersgegevens (IPD)
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NEE
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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Nee
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