Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
29. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
32
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Moscow, Russland
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
- 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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: first group
Patients will receive a free connective tissue graft without an epithelial collar
|
|
|
Experimental: second group
Patients will receive a free connective tissue graft with epithelial collar
|
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the Width of Keratinized Mucosa
Zeitfenster: Day 90 compared to the 0th day (initial value)
|
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.
|
Day 90 compared to the 0th day (initial value)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the Width of Keratinized Mucosa
Zeitfenster: Day 180 compared to the 0th day (initial value)
|
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.
|
Day 180 compared to the 0th day (initial value)
|
|
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Zeitfenster: Day 90 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.
|
Day 90 compared to the 0th day (initial value)
|
|
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Zeitfenster: 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.
|
Day 180 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Zeitfenster: 4 hours 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.
|
4 hours compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Zeitfenster: Day 1 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.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Zeitfenster: 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.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Zeitfenster: 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.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Zeitfenster: 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.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
Zeitfenster: Day 1 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 1 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
Zeitfenster: 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)
|
|
Assessment of Postoperative Swelling Severity
Zeitfenster: 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)
|
|
Assessment of Postoperative Swelling Severity
Zeitfenster: 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.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
Zeitfenster: Day 1 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 1 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
Zeitfenster: 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)
|
|
Assessment of Bleeding
Zeitfenster: 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)
|
|
Assessment of Bleeding
Zeitfenster: 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)
|
|
Assessment of Analgesic Intake
Zeitfenster: Day 1 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
|
Quality of Life Assessment According to OHIP-14
Zeitfenster: Day 0 (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 0 (initial value)
|
|
Quality of Life Assessment According to OHIP-14
Zeitfenster: 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)
|
|
Quality of Life Assessment According to OHIP-14
Zeitfenster: Day 90-93 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 90-93 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
Zeitfenster: Day 180-186 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 180-186 compared to the 0th day (initial value)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Igor P Ashurko, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. Juni 2024
Primärer Abschluss (Geschätzt)
20. Juni 2026
Studienabschluss (Geschätzt)
20. August 2026
Studienanmeldedaten
Zuerst eingereicht
29. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
4. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- AI-05
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .