Objective

The objective of this systematic review was to test the hypothesis of no difference in implant treatment outcomes when using Bio-Oss alone or Bio-Oss mixed with PABG as graft material for LRA.

Consideration of eligibility criteria for this review

The inclusion criteria were developed using the PICO guidelines and included human studies evaluating LRA with Bio-Oss alone or Bio-Oss mixed with PABG ( Table 1 ). Moreover, non-comparative human studies assessing LRA with Bio-Oss alone or Bio-Oss mixed with PABG were also included.

Outcome measures

The primary outcome measures are the most important measures for evaluating the final treatment outcome. Secondary outcome measures were also included in this systematic review as surrogate measures, due to the lack of studies focusing on the primary outcome measure.

The primary outcome measures were (1) the survival of suprastructures: loss of the suprastructure was defined as total loss due to a mechanical and/or biological complication; (2) the survival of implants: loss of implants was defined as non-integrated implants, mobility of previously clinically osseointegrated implants, and removal of non-mobile implants due to progressive peri-implant marginal bone loss or infection.

Moreover, the following secondary outcome measures were assessed: (1) bone regeneration, assessed by histological measurements; (2) width gained at the alveolar process, assessed by clinical or radiographic measurements; (3) width reduction of the graft material, assessed by two-dimensional measurements; (4) volumetric stability of the graft material, assessed by three-dimensional measurements; (5) patient-reported outcome measures; (6) complications related to the surgical procedure.

Search strategy

A search of the MEDLINE (PubMed), Cochrane Library, and Embase databases was conducted. Human studies published in English from 1 January 1990 to 1 May 2016 were included. The search strategy utilized a combination of controlled vocabulary terms (medical subject headings, MeSH) and free text terms. The headings were (alveolar ridge augmentation OR alveolar AND ridge augmentation) AND (lateral OR horizontal) AND (Bio-Oss OR bone substitute OR bovine bone OR xenograft).

The search was supplemented by a thorough hand-search, page by page, of relevant journals. The manual search also included the bibliographies of all articles selected for full-text screening, as well as previously published reviews relevant to the present systematic review. The search was performed by two reviewers (HCA and TJ). Any disagreement between the two observers was resolved by consensus.

Study selection

The titles of the identified reports were initially screened. The abstract was assessed when the title indicated that the study fulfilled the inclusion criteria. Full-text analysis was performed when the abstract was unavailable or when the abstract indicated that the inclusion criteria were fulfilled. The study selection process was performed by two reviewers (HCA and TJ). Any disagreement between the two observers was resolved by consensus.

Inclusion criteria

Human studies assessing the outcome of LRA with Bio-Oss alone or mixed with PABG were included; these studies addressed the previously described outcome measures. The review exclusively focused on studies applying LRA in non-prepared sites with delayed implant installation. In addition, at least five patients had to have been included in the study. Studies including both lateral and vertical ridge augmentation were included if the outcome measures for LRA alone could be clearly identified. Studies comparing Bio-Oss with autogenous bone graft alone were included if the outcome measures could be identified for Bio-Oss alone or in combination with PABG.

Exclusion criteria

Studies using Bio-Oss blocks alone or Bio-Oss blocks in combination with granules were excluded if the outcome measures could not be identified for granules alone . In addition, studies using an unknown ratio of Bio-Oss to PABG were excluded, as well as studies applying immediate implant placement .

Quality assessment

A quality assessment of the included studies was undertaken by one review author (HCA) as part of the data extraction process. The quality assessment was performed according to the following parameters: (1) adequate randomization (yes/no); (2) blinding of outcome measurement (yes/no); (3) completeness of follow-up; a clear explanation for withdrawals and drop-outs (yes/no); (4) histological evaluation involving unbiased stereological methods (yes/no).

The studies were defined as having a low risk of bias (plausible bias unlikely to seriously alter the results) if all of the quality criteria described above were met, or as having a high risk of bias (plausible bias that seriously weakens confidence in the results) if any of the quality criteria described above were not met.

Data extraction

Data were extracted by one reviewer (HCA) according to the data collection form, ensuring systematic recording of the outcome measures. In addition, relevant characteristics of the studies were recorded. In the case of any uncertainty, another reviewer was consulted (TJ).

Data synthesis

The studies included in the review revealed considerable variations in design, i.e. width of the alveolar process, ratio of Bio-Oss and PABG, presence or absence of a barrier membrane, length of the observation period, and types of outcome measure. Therefore, a meta-analysis was not possible for the present review.

Description of studies

A flow diagram of the search process is given in Fig. 1 . A total of 337 titles were identified and 179 abstracts were reviewed. The full-text analysis resulted in six articles for inclusion; these articles reported six non-comparative studies . No studies were included as a result of the hand-search.

Study screening process.

LRA was performed with Bio-Oss alone in two studies . The other four studies used different mixtures of Bio-Oss and PABG , involving 50% Bio-Oss and 50% PABG , 60% Bio-Oss and 40% PABG , and 90% Bio-Oss and 10% PABG . In all studies, the autogenous bone graft was harvested from the mandible. In one study, three different regions were used for the harvesting procedure: the retromolar region, the ascending mandibular ramus, and the symphysis region . The retromolar region alone was used in two studies and the ascending mandibular ramus in one study . The use of a covering membrane varied between the studies, including the use of a non-resorbable membrane , a resorbable membrane , no membrane and fibrin glue15, or a resorbable membrane in combination with fibrin glue18. The main results are described and summarized in Tables 2 and 3 .

Table 3

Non-comparative studies with Bio-Oss mixed with particulate autogenous bone graft. ^a

Ref.	Patients	Materials and methods	Follow-up	Implants, n	Results						Conclusion
					Primary outcome	Secondary outcomes
					Implant survival	New bone formation	Gain in ridge width	WRG	VS	Complications
Hellem et al. 2003	24	24 sites: 50% Bio-Oss and 50% PABG	6 months,	74	95.9%	NR	NR	NR	NR	Abutment fracture: 1	Mixture of 50% Bio-Oss and 50% PABG useful for LRA
			1 year,
			3 years
										Facing fractures of SS: 2
Urban et al. 2011	16	18 sites: 50% Bio-Oss, 50% PABG and resorbable synthetic membrane	38.8 months	42	100%	No difference in amount of NFB in apical and coronal parts	5.56 mm	NR	NR	NR	PAGB in combination with Bio-Oss covered by resorbable membrane is effective for LRA
Mordenfeld et al. 2013	13	14 sites: 60% Bio-Oss and 40% PABG	7.5 and 8 months	71	NR	NFB, 20%	At 3 mm from top of crest: 3.5 mm	37%	53.8%	Postoperative dehiscence: 7	Significantly less graft width reduction with mixture 60:40 compared with mixture 90:10
						Bio-Oss, 28.3%	At 6 mm from top of crest: 4.5 mm				No histomorphometric differences between groups
						NMT, 51.6%
		14 sites: 90% Bio-Oss and 10% PABG			NR	NFB, 22.7%	At 3 mm from top of crest: 2.9 mm	46.9%	55.3%
						Bio-Oss, 30.1%	At 6 mm from top of crest: 4.0 mm
						NMT, 47.3%
Urban et al. 2013	25	31 sites: 50% Bio-Oss, 50% PABG and resorbable collagen membrane	8.9 and 20.9 months	76	100%	NFB, 31.0%	5.68 mm	NR	NR	Abscess at graft site:1	This treatment can be regarded as successful
						Bio-Oss, 25.8%				Patient was retreated with a successful result
						NMT, 43.2%

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