Date trial registered
Jan 3, 2020
Incorporation of the first participant
Feb 11, 2020
Recruitment status
Complete
Academic title
(Data source: WHO)
A MULTICENTER RANDOMIZED CONTROLLED STUDY COMPARING EARLY IMPLANT PLACEMENT TO ALVEOLAR RIDGE PRESERVATION FOR SINGLE TOOTH REPLACEMENT IN THE ANTERIOR AREA - RP vs EP
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: prevention
Phase
(Data source: WHO)
4
Primary end point
(Data source: WHO)
The primary outcome will be contour changes (mm) at the buccal aspect of the extraction site from pre-tooth extraction (baseline) to 5 months later by volumetric analysis.
Secundary end point
(Data source: WHO)
? profilometric outcomes (horizontal changes) at screening, T0, T1, T2, T3, T4, T5, T6.
? clinical parameters (probing depth, bleeding on probing, plaque index, keratinized mucosa) at screening, T3, T4, T5, T6 by using a dental probe
? aesthetic (PES, WES) at screening, T3, T4, T5, T6 by dentist's score
? marginal bone level and buccal bone thickness at T0, T2, T3, T6 by radiographic methods
?i mplant survival at T3, T4, T5, T6 by observing whether the implant is in place or not
? patient-reported outcome measures at T0, T1, T2, T3, T4, T5, T6 by questionnaires
? costs at T3, T4, T5 and T6.
? need for additional Guided Bone Regeneration at T1, T2.
? need for an additional soft tissue grafting procedure at T2.
? Dentist's VAS score for ease of treatment for the dentist at T0, T1, T2.
? Dentist's VAS for Treatment Satisfaction for the dentist at T3,T4,T5,T6
? Technical parameters at T3, T4,T5,T6 by using USPHS criteria
Contact information
(Data source: WHO)
ITIFoundation
