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Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants

5. maj 2026 opdateret af: Mansoura University
Aim of the study The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Therefore, the primary objective is to evaluate the integration of porcine collagen matrix with the recipient site and measuring the amount gained of keratinized mucosa. The secondary objective is to assess the pink esthetic score around dental implant following porcine collagen matrix compared to the free gingiva graft.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Al Mansurah, Egypten
        • faculty of dentistry Mansoura university, Mansoura, 35516

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Patient between 25-50 years old.
  2. Remaining bone height of more than 8 mm, remaining bone width of 6 mm
  3. Inadequate keratinized soft tissue <2 mm (13).
  4. Favorable pattern of occlusion.
  5. Good oral hygiene.
  6. Patient ability to comply with the required recall visits.

Exclusion Criteria:

  1. Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
  2. Patients having any uncontrolled systemic disease which could affect bone healing.
  3. Patients treated with radiotherapy to the head and neck area within the past 12 months.
  4. Heavy Smokers (more than 20 cigarette per day) according to WHO.
  5. Inability or unwillingness to return for follow-up visits.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).

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.
Eksperimentel: 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.
Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Evaluation:
Tidsramme: 3 months

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
clinical
Tidsramme: 3 months

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
Clinical
Tidsramme: 3 months

Surgical Operation Time: Duration of implant site preparation and graft fixation.

Unit: Minutes. Time Frame: During surgery.
3 months
clinical
Tidsramme: 3 months

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical periodontal parameters
Tidsramme: 3 months

Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index.

Unit: PI score. Time Frame: 3 months post-operatively.
3 months
radiographic
Tidsramme: 6 months

  1. Implant Position Accuracy

    Description:

    Evaluation of the accuracy of dental implant placement in relation to adjacent teeth and surrounding vital anatomical structures using Cone Beam Computed Tomography (CBCT).

    Unit of Measure:

    Deviation distance in millimeters (mm)

    Time Frame:

    At 6 months post-implant placement

  2. Crestal Bone Level Changes - Mesiodistal

    Description:

    Measurement of crestal bone level changes in the mesiodistal direction around the dental implant using CBCT.

    Unit of Measure:

    Millimeters (mm)

    Time Frame:

    At 6 months post-implant placement

  3. Crestal Bone Level Changes - Buccolingual

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
clinical parameters
Tidsramme: 3 months

Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health.

Unit: mm. Time Frame: 3 months post-operatively.
3 months
clinical perodontal parameters
Tidsramme: 3 months

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
clinical periodontal parameters
Tidsramme: 3 months

Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site.

Unit: mm. Time Frame: 3 months post-operatively.
3 months
clinical periodontal parameters
Tidsramme: 3 months
Gingival Thickness (GT): Thickness of peri-implant gingiva. Unit: mm. Time Frame: 3 months post-operatively.
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mansoura University

Efterforskere

  • Ledende efterforsker: mohamad sa haichal, bachelor, Faculty of Dentistry Mansoura University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2025

Primær færdiggørelse (Anslået)

28. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

17. januar 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • A0101025 OM

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