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Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps

NCT ID: NCT05211115

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2024-12-01

Brief Summary

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Randomized, outcome assessor and data analyst blinded, single center trial with four parallel arms and a 1:1:1:1 allocation ratio, with the aim of comparing which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous or xenogeneic) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures

Detailed Description

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This randomized four parallel arms controlled clinical trial with blinded outcome assessment and data analysis aims to establish which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous subepithelial connective tissue graft vs. volume stable collagen matrix) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures. The primary outcome is the gain in soft tissue thickness (standardised measurement at baseline, after surgery, at 1m and 6m). Secondary outcomes include changes in tissue volume (intraoral scans at baseline, post-op, 14d, 1m, 6m), RAL and KTW (clinical measurements at baseline, 1m, 6m), tissue color integration (∆E at 1m and 6m), and PROMS (7d, 14d, 30d). Exploratory outcomes include tissue morphology (histology at 1m,2m,4m,6m), microcirculation (Doppler flowmetry at pre-op, 7d, 14d, 1m) and revascularization (IHC at 1m,2m,4m,6m). A figure of 10 subjects per group was obtained for a 0,3mm difference in tissue thickness increase (SD 0,23mm), using 80% power, alpha 0.05, and a 10% drop-out rate. Patients will be randomly allocated to four groups: test (STF+VCM), control 1 (FTF+VCM), control 2 (SFT+CTG), control 3 (FTF+CTG). Patients will be the unit of analysis and ANOVA (normality) or Kruskall-Wallis (no normality) tests will be performed setting the significance level at p \< 0.05.

Conditions

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Thin Gingiva

Keywords

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Soft tissue management Dental implant Collagen matrix Connective tissue graft Split thickness flap Full thickness flap

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Split thickness flap + Volume stable collagen matrix

A split thickness flap will be raised with a micro-blade, keeping a flap thickness \>0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 6mm thick volume stable collagen matrix will be stabilised at the inner aspect of the flap.

Group Type EXPERIMENTAL

Split thickness flap

Intervention Type PROCEDURE

Palatally displaced crestal incision at the edentulous site, combined with the split thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a micro-blade, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Volume stable collagen matrix

Intervention Type PROCEDURE

Geistlich Fibro-Gide® matrix shaped at a standardised dimension of 10mm (mesio-distally) by 6-8mm (apico-coronally) by 6mm (thickness). Matrix stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Full thickness flap + Volume stable collagen matrix

A full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide by 6-8mm high volume stable collagen matrix will be stabilised at the inner aspect of the flap.

Group Type ACTIVE_COMPARATOR

Full thickness flap

Intervention Type PROCEDURE

Palatally displaced crestal incision at the edentulous site, combined with the full thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a fine periosteal elevator, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Volume stable collagen matrix

Intervention Type PROCEDURE

Geistlich Fibro-Gide® matrix shaped at a standardised dimension of 10mm (mesio-distally) by 6-8mm (apico-coronally) by 6mm (thickness). Matrix stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Split thickness flap + Autogenous connective tissue

A split thickness flap will be raised with a micro-blade, keeping a flap thickness \>0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap.

Group Type ACTIVE_COMPARATOR

Split thickness flap

Intervention Type PROCEDURE

Palatally displaced crestal incision at the edentulous site, combined with the split thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a micro-blade, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Autogenous sub epithelial connective tissue graft

Intervention Type PROCEDURE

Harvest of a sub epithelial connective tissue graft using a double incision technique, approximately 2-3 mm apical to the palatal gingival margins of the first and second premolars. Graft dimension standardised as 10mm (mesio-distally) by 6-8mm (apico-coronally) by 1,5mm (thickness). Graft stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Full thickness flap + Autogenous connective tissue

A full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap.

Group Type ACTIVE_COMPARATOR

Full thickness flap

Intervention Type PROCEDURE

Palatally displaced crestal incision at the edentulous site, combined with the full thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a fine periosteal elevator, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Autogenous sub epithelial connective tissue graft

Intervention Type PROCEDURE

Harvest of a sub epithelial connective tissue graft using a double incision technique, approximately 2-3 mm apical to the palatal gingival margins of the first and second premolars. Graft dimension standardised as 10mm (mesio-distally) by 6-8mm (apico-coronally) by 1,5mm (thickness). Graft stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Interventions

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Split thickness flap

Palatally displaced crestal incision at the edentulous site, combined with the split thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a micro-blade, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Intervention Type PROCEDURE

Full thickness flap

Palatally displaced crestal incision at the edentulous site, combined with the full thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a fine periosteal elevator, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.

Intervention Type PROCEDURE

Autogenous sub epithelial connective tissue graft

Harvest of a sub epithelial connective tissue graft using a double incision technique, approximately 2-3 mm apical to the palatal gingival margins of the first and second premolars. Graft dimension standardised as 10mm (mesio-distally) by 6-8mm (apico-coronally) by 1,5mm (thickness). Graft stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Intervention Type PROCEDURE

Volume stable collagen matrix

Geistlich Fibro-Gide® matrix shaped at a standardised dimension of 10mm (mesio-distally) by 6-8mm (apico-coronally) by 6mm (thickness). Matrix stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Any male or female adult (≥ 18 year old) patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting a submerged dental implant scheduled to undergo a second stage surgery, which is bounded mesially or distally by a remaining natural tooth, and exhibits a lack of buccal soft tissue volume, will be potentially eligible for this trial.

The case definition for a lack of buccal soft tissue volume will be the presence of a thin buccal mucosa (\< 2mm) or a minor volumetric contraction of the alveolar process (flat or concave buccal mucosal profile at the edentulous area).

Exclusion Criteria

* Compromised general health status contraindicating the study procedures (≥ASA IV);
* Drug abuse, alcohol abuse, or smoking \> 10 cigarettes a day;
* Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
* Assumption of bisphosphonates (any type, any dose, past or present);
* Pregnant or nursing women;
* Hypersensitivity to paracetamol;


* History of previous mucogingival surgeries in the area of interest;
* Lack of adequate vestibule depth to perform a bilaminar procedure;
* Lack of osseointegration at the time of implant reopening;
* Need for additional bone grafting at the time of implant reopening;
* Intraoperative evidence of a flap thickness \< 0,5mm or \> 2mm.


\- Non compliant patients: poor oral hygiene at 2 consecutive visits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osteology Foundation

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano Sanz Alonso

Role: STUDY_CHAIR

Faculty of Odontology, University Complutense, Madrid, Spain

David Palombo

Role: STUDY_DIRECTOR

Faculty of Odontology, University Complutense, Madrid, Spain

Locations

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Department of Periodontology, University Complutense Madrid, Spain

Madrid, , Spain

Site Status

Countries

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Spain

References

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Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.

Reference Type RESULT
PMID: 28000281 (View on PubMed)

Johnston WM, Kao EC. Assessment of appearance match by visual observation and clinical colorimetry. J Dent Res. 1989 May;68(5):819-22. doi: 10.1177/00220345890680051301.

Reference Type RESULT
PMID: 2715476 (View on PubMed)

McLean TN, Smith BA, Morrison EC, Nasjleti CE, Caffesse RG. Vascular changes following mucoperiosteal flap surgery: a fluorescein angiography study in dogs. J Periodontol. 1995 Mar;66(3):205-10. doi: 10.1902/jop.1995.66.3.205.

Reference Type RESULT
PMID: 7776165 (View on PubMed)

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

Reference Type RESULT
PMID: 3670870 (View on PubMed)

Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.

Reference Type RESULT
PMID: 28609502 (View on PubMed)

Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23.

Reference Type RESULT
PMID: 29334403 (View on PubMed)

Sanz-Martin I, Encalada C, Sanz-Sanchez I, Aracil J, Sanz M. Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisional restorations: A prospective case series. Clin Implant Dent Relat Res. 2019 Feb;21(1):145-153. doi: 10.1111/cid.12696. Epub 2018 Dec 3.

Reference Type RESULT
PMID: 30508313 (View on PubMed)

Tatarakis N, Gkranias N, Darbar U, Donos N. Blood flow changes using a 3D xenogeneic collagen matrix or a subepithelial connective tissue graft for root coverage procedures: a pilot study. Clin Oral Investig. 2018 May;22(4):1697-1705. doi: 10.1007/s00784-017-2261-5. Epub 2017 Oct 27.

Reference Type RESULT
PMID: 29080078 (View on PubMed)

Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.

Reference Type RESULT
PMID: 27310522 (View on PubMed)

Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.

Reference Type RESULT
PMID: 29498129 (View on PubMed)

Other Identifiers

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19-102

Identifier Type: -

Identifier Source: org_study_id