A study comparing two dental implant preparation techniques and their effect on bone levels over three years

ISRCTN	ISRCTN81043520
DOI	https://doi.org/10.1186/ISRCTN81043520
Sponsor	Alpha Bio Tec
Funder	Alpha Bio Tec

Submission date: 17/02/2026
Registration date: 18/02/2026
Last edited: 18/02/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Prof Luigi Canullo
Principal investigator, Public, Scientific

Via Nizza, 46
Roma
00198
Italy

ORCID ID	0000-0001-9875-2929
Phone	3476201976
Email	luigicanullo@yahoo.com

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Hybrid funnel technique vs Conventional drill osteotomy: a novel approach for implant site preparation.
Study objectives
Ethics approval(s)	Approved 22/06/2022, Lazio 1 Ethics Committee (Comitato Etico Lazio 1) (San Camillo Hospital, Circonvallazione Gianicolense 87, Rome, 00152, Italy; 06 58701; comitatoetico.lazio1@hsanf.it), ref: 904
Health condition(s) or problem(s) studied	Dental implant rehabilitation in adults requiring implants, comparing two implant site preparation techniques and their effects on marginal bone levels and peri-implant clinical parameters
Intervention	Participants are adults requiring implant rehabilitation in the maxilla and/or mandible who meet predefined eligibility criteria and provide written informed consent. All participants receive bioactive-surface dental implants (NINA MultiNeO NH, Alpha-Bio Tec) placed under local anaesthesia using a computer-guided surgical template. Participants are allocated pre-operatively to one of two group using a non-randomised allocation protocol aimed at maintaining clinical comparability for age, sex, implant site and bone characteristics. In the control group, implant osteotomies are prepared with a conventional subtractive drilling sequence according to the manufacturer’s instructions (pilot drill followed by step and final drills to full planned length), and implants are inserted. In the test group, osteotomies are prepared using the Hybrid Funnel Technique, combining subtractive drilling to length with selective crestal cortical preparation using a wider drill and medullary osteocompaction using a dedicated osteotome prior to implant insertion, creating a funnel-shaped osteotomy. Insertion torque is recorded at placement and implant stability is assessed by resonance frequency analysis; a baseline periapical radiograph is taken at surgery. Participants enter a structured clinical and radiographic follow-up and supportive periodontal care programme with periodic visits (typically every 3–6 months). The primary outcome is radiographic marginal bone loss from baseline to 3 years assessed on standardized periapical radiographs. Secondary outcomes include bleeding on probing and plaque index assessed during follow-up.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Radiographic marginal bone loss (MBL) measured using standardized periapical radiographs (mm) at 3 years follow up
Key secondary outcome measure(s)	Plaque Index (PI) measured using the Plaque Index score (Silness and Löe scale, 0–3) at 3 years follow-up Bleeding on Probe (BOP) measured using the bleeding score (Modified Mombelli index, 0–3) at 3 years follow-up
Completion date	22/01/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	30 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	80
Total final enrolment	43
Key inclusion criteria	1. Patients requiring implant rehabilitation in the maxillary and/or mandibular bone 2. ASA physical status I–II 3. Age between 30 and 85 years 4. Healthy or treated periodontal conditions (treated periodontitis, PI <25%, BoP <25%) 5. Willingness to sign the informed consent and to participate in the clinical study
Key exclusion criteria	1. Absence of type 1–2 post-extraction sites 2. ASA physical status III–IV 3. Untreated periodontitis 4. Sites with a history of previous implant failure 5. Known allergy to one or more medications used during treatment 6. Pregnancy (confirmed by verbal inquiry)
Date of first enrolment	29/07/2022
Date of final enrolment	14/11/2023

Locations

Countries of recruitment

Italy

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Luigi Canullo, luigicanullo@yahoo.com.

Editorial Notes

18/02/2026: Study’s existence confirmed by the Lazio 1 Ethics Committee, Italy.