Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
9 giugno 2018 aggiornato da: Marmara University
The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment.
Forty-eight patients with high papillary frenulum attachments were included in the study.
Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P).
Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS).
Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days.
Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days.
All data were compared between groups and within each group.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
48
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.
Exclusion Criteria:
- Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Conventional Frenectomy
For the conventional surgery, after application of local infiltration anesthesia of articaine HCL associated with epinephrine 1:100,000, the frenulum was grasped with a straight haemostat inserted into the depth of the vestibule; the tissue adjacent to the upper and lower surfaces of the haemostat was incised with a no.15 scalpel.
After the diamond shaped resected portion of the frenulum was removed with the haemostat, muscle dilatations were excised on the submucosa of the lateral walls of the cavity.
Horizontal incision was made on the periosteum with the help of a scalpel following the procedure.
At the end of the operation, the wound was closed with absorbable sutures (4-0, Pegelak®, Doğsan Turkey).
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Frenectomy operation performed by surgical blades with suturing.
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Sperimentale: Diode Laser Frenectomy
For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure.
The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000.
The frenlum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre).
The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum or any bone structure.Following the bleeding control, the wound site was left to secondary healing.
No sutures were necessary after procedure.
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Diode Laser assisted frenectomy operation.
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Sperimentale: Laser Frenectomy with Incision
For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure.
The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000.
The frenulum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre).
The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum.
Horizontal incision was made on the periosteum with the help of a scalpel, additionally.
No sutures were necessary after procedure.
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Diode Laser assisted frenectomy operation.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative Pain Change
Lasso di tempo: Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
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Postoperative pain during eating and speaking will be evaluate via visual analog scale (VAS).Visual Analogue Scale (VAS) was used to evaluate pain, discomfort during speaking and chewing.
VAS consisted of a horizontal line with a range of numbers from '0' to '10' of which '0' means 'no pain' and '10' means unbearable pain.
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Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 settembre 2016
Completamento primario (Effettivo)
1 ottobre 2017
Completamento dello studio (Effettivo)
1 ottobre 2017
Date di iscrizione allo studio
Primo inviato
31 marzo 2018
Primo inviato che soddisfa i criteri di controllo qualità
9 giugno 2018
Primo Inserito (Effettivo)
12 giugno 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2018
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Cetinkaya et al.
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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