Orthodontic mini-implants (OMI) provide predictable anchorage and facilitate orthodontic tooth movement. The objective of the present systematic review and meta-analysis was to assess randomized controlled trials (RCTs) comparing the placement accuracy of OMI inserted using guided and freehand techniques (FT).

An electronic search was conducted in PubMed, Scopus, EMBASE, Web of Science, Cochrane Library, and Google Scholar databases until February 2026, without time or language restrictions. The focused question is: “Is guided placement of OMI more accurate than freehand placement?” A literature search was conducted using MeSH and Boolean operators. Solely RCTs were included and processed for data extraction. Handsearching was also performed, and disagreements were resolved via discussion. Risk of bias (RoB) and certainty of evidence (CoE) were assessed using the Cochrane RoB Tool and the GRADE analysis, respectively. A quantitative meta-analysis was performed using a validated computer-based software.

Four RCTs involving 12–42 participants were included. The number of OMI placed using guided and FT protocols ranged between 12–42 and 12–42, respectively. Three trials assessed quantitative outcomes (angular and/or linear deviation measures) and one evaluated implant failure rates. Three RCTs reported that guided protocols yielded higher placement accuracy than FT. One RCT reported that implant failure rates did not differ significantly between the guided and FT placement protocols. Three RCTs demonstrated a low RoB, and one raised some concerns. The overall CoE was rated as low. A pooled meta-analysis of two RCTs demonstrated a consistent direction of effect favouring the guided implant placement.

Given the limited number of included RCTs, the overall low CoE, and the absence of comprehensive qualitative assessments across all studies, it remains inconclusive whether guided protocols for OMI placement offer a definitive advantage over the FT or vice versa.

PROSPERO ID # CRD420261293388.