- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07780227
Laser Modification of Dental Implant Abutment Surfaces
19. august 2026 opdateret af: Alexandria University
Impact of Surface Modification of Abutments of Dental Implants by Laser on Soft Tissue Seal (A Randomized Controlled Clinical Trial)
Introduction: Tight soft tissue integration to the dental implants is essential to achieve a successful outcome of dental implants.
Contamination by oral bacteria of the implant-mucosa interface can result in gingival recession, pocket formation, and bone resorption.
There are many surface modification strategies to reinforce the soft tissue seal to dental implants.
One of these strategies is laser technology.
The aim of this study is to evaluate the effect of laser-induced roughness of titanium surfaces of final abutments on the connective tissue seal to the dental implant.
Materials and Methods: Twenty-four pure titanium abutments of dental implants will be evaluated in this study.
The abutments will be divided into 2 groups: group A will be treated with ND: YAG laser, and group B will not be treated with a laser as a control group.
After 3 months, evaluation will be done by measuring peri-implant probing depth, modified gingival index, bleeding index, plaque index, and patient satisfaction.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alexandria, Egypten
- Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
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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
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- An informed consent will be signed from all the volunteers and they will be informed with all the steps, risk and benefits regarding the study.
- Patients having osseointegrated implants ready to receive final abutment.
Exclusion Criteria:
- The presence of chronic systemic disease.
- Smoking of more than 10 cigarettes per day.
- Bruxism habits.
- Alcohol or drug abuse.
- Poor oral hygiene.
- Pregnancy
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 |
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Aktiv komparator: Kontrolgruppe
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will include twelve abutments which will be left machined (as received from the manufacturer) to serve as controls.
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Eksperimentel: Studiegruppe
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This will include twelve titanium abutments treated by ND: YAG laser with an output power 4 W, representing 80mJ for a period of 5 seconds (20).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in peri-implant probing depth
Tidsramme: up to 3 months
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Desirable probing depths around dental implants are 2.5mm to 4mm.
Peri-implantitis is often defined by the incidence of peri-implant probing depth ≥ 5 mm associated with bleeding on probing
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up to 3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in Modified gingival index (MGI)
Tidsramme: up to 3 months
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the scoring will be as follows: 0 = absence of inflammation,
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up to 3 months
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chaneg in Bleeding index (BI)
Tidsramme: up to 3 months
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The Bleeding Index (modified Index of Saxton), will be performed by using a dental probe.
The probe will be engaged approximately 1 millimetre (mm) into the gingival crevice.
A moderate pressure will be used while sweeping.
The scoring system is as follows: 0 = no bleeding after 30 seconds, 1 = bleeding upon probing after 30 seconds, 2 = immediate bleeding observed
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up to 3 months
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change in Plaque index
Tidsramme: up to 3 months
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0 = no plaque.
1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
3 = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth, 4= more than 1/3 but less than 2/3 of the tooth is covered with plaque , 5 indicated that more than 2/3 of the tooth surface is covered with plaque
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up to 3 months
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Patient satisfaction
Tidsramme: up to 3 months
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Patient satisfaction will be assessed using a visual analogue scale (VAS)
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up to 3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
15. juni 2025
Primær færdiggørelse (Faktiske)
25. december 2025
Studieafslutning (Faktiske)
30. december 2025
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1078-05/2025
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