Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram

	Study period
	Enrollment	Allocation	Post allocation
Time point	Pretreatment	t ₀	Baseline	Implant placement	t ₁	t ₆	t ₁₂
Enrollment:
Eligibility screen	x
Informed consent	x
Allocation		x
Interventions:
Conventional denture (control group)		x	x			x	x
Single-implant mandibular overdenture (SIMO) (intervention group)		x	x	x	x	x	x
Assessments:
Oral health-related quality of life (OHRQoL)			x			x	x
Satisfaction with dentures			x			x	x
Masticatory performance			x			x	x
Implant stability^a				x	x		x
Peri-implant bone level^a					x	x	x
Peri-implant soft tissue health^a					x	x	x
Prosthodontic events
Costs

ISSN: 1745-6215