Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Al Mansurah, Ägypten
- faculty of dentistry Mansoura university, Mansoura, 35516
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Patient between 25-50 years old.
- Remaining bone height of more than 8 mm, remaining bone width of 6 mm
- Inadequate keratinized soft tissue <2 mm (13).
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
Exclusion Criteria:
- Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
- Patients having any uncontrolled systemic disease which could affect bone healing.
- Patients treated with radiotherapy to the head and neck area within the past 12 months.
- Heavy Smokers (more than 20 cigarette per day) according to WHO.
- Inability or unwillingness to return for follow-up visits.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: dental implant with application of free gingival graft
Group I: will include 10 patients in which participants will receive dental implant with application of free gingival graft which will be taken from the hard palate to increase the width of keratinize gingiva
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Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture. |
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Experimental: dental implants with application of porcine collagen matrix
Group II: will include 10 patients in which participants will receive dental implants with application of porcine collagen matrix to increase the width of keratinize gingiva.
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Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Clinical Evaluation:
Zeitfenster: 3 months
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Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection. Unit: Yes/No. Time Frame: Post-operative follow-up visits. |
3 months
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clinical
Zeitfenster: 3 months
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Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell). Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months. |
3 months
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Clinical
Zeitfenster: 3 months
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Surgical Operation Time: Duration of implant site preparation and graft fixation. Unit: Minutes. Time Frame: During surgery. |
3 months
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clinical
Zeitfenster: 3 months
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Post-operative Pain Intensity: Patient-reported pain measured using Visual Analogue Scale (VAS). Unit: VAS score (0-10). Time Frame: Day 1, Day 3, and 1 week post-operatively. |
3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Clinical periodontal parameters
Zeitfenster: 3 months
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Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index. Unit: PI score. Time Frame: 3 months post-operatively. |
3 months
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radiographic
Zeitfenster: 6 months
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Description: Measurement of crestal bone level changes in the buccolingual direction around the dental implant using CBCT. Unit of Measure: Millimeters (mm) Time Frame: At 6 months post-implant placement |
6 months
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clinical parameters
Zeitfenster: 3 months
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Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health. Unit: mm. Time Frame: 3 months post-operatively. |
3 months
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clinical perodontal parameters
Zeitfenster: 3 months
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Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket. Unit: mm. Time Frame: 3 months post-operatively. |
3 months
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clinical periodontal parameters
Zeitfenster: 3 months
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Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site. Unit: mm. Time Frame: 3 months post-operatively. |
3 months
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clinical periodontal parameters
Zeitfenster: 3 months
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Gingival Thickness (GT): Thickness of peri-implant gingiva.
Unit: mm.
Time Frame: 3 months post-operatively.
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3 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: mohamad sa haichal, bachelor, Faculty of Dentistry Mansoura University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- A0101025 OM
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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