Volumetric Assessment of Volume Stable Collagen Matrix in Soft Tissue Ridge Augmentation
Condition: Buccal Defect at Implant Sites
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This proposal suggests the use of a collagen scaffold as a core material for GBR in the case
      of a missing tooth between two existing teeth, in situations where there is sufficient bone
      to place an implant but a horizontal defect is present in the ridge.

      The tested question is whether a thick, reinforced, resorbable collagen scaffold can provide
      a stable basis for restoring the lost volume of a deficient ridge. As a secondary aim, a
      positive result could present an option to replace the connective tissue interpositional
      graft procedure.
    

Detailed description: 
      • Surgical procedure and clinical measurements:

      Pre-surgical phase:

        1. Full Conventional non-surgical periodontal therapy involving supra, sub gingival scaling
           and root planning will be performed

        2. Oral hygiene instructions will be repeated until patients had achieved a proper degree
           of oral hygiene where plaque index (PI) ≤ 1.

        3. Four weeks later, patients will be re-evaluated in order to confirm the efficacy of
           cause related therapy phase.

        4. Clinical parameters and CBCT will be recorded prior to surgery.

        5. Full arch impressions will be recorded with high viscosity impression material. Baseline
           casts will be made to be used as a reference for volumetric measurements.

             -  Surgical protocol:

             -  Patients will undertake implant surgery under local anesthesia for the missing
                tooth using mid crestal incision at the edentulous area and sulcular incisions at
                the neighboring mesial and distal teeth.

             -  A combined full / partial thickness flap will be made followed by implant placement
                and healing screw is connected to the implant.

             -  For group 1 VCMX will be utilized to graft the buccal defect and primary closure
                will be achieved using simple interrupted sutures.

             -  For group 2 CTG will be utilized to graft the buccal defect and primary closure
                will be achieved using simple interrupted sutures.

             -  Postoperative medications will include (Augmentin 1g twice/day, Flagel 500 mg twice
                daily and 2 weeks of antiseptic mouth wash ).(Deeb et al , 2015)

             -  Patients will be given post-operative instruction and sutures will be removed after
                2 weeks.

             -  The final abutment will be secured to the implant within 12 weeks after gingival
                healing for definitive crown placement.

      Postoperative surgical evaluation and assessment:

        -  The follow up period will include oral examination, plaque removal when necessary, at
           the surgical site.

        -  Clinical parameters will be measured, impressions redone, and models will be casted 3, 6
           and 9 months postoperatively for both groups.

        -  Radiographic examination using CBCT will be done at 9 months follow up.

      Methods of evaluation:

        1. Clinical Measurements:

             -  Probing depth (Glavind & Loe, 1967).

             -  Plaque index (O'leary T, 1972).

             -  Bleeding index (Newbrun, 1996)

             -  Volumetric changes at the augmented implant site digitally through scanning model
                casts.

           To assess the volumetric differences between the baseline, 3, 6 and 9 months
           postoperatively and all the cast models will be transferred to digital replica using an
           optical scanner. Digital replicas will be produced resembling various time intervals
           during treatment. Superimposing the different replicas of each case utilizing the best
           fit algorithm by using reference points from the tooth surfaces. The implant site region
           will be delineated by the mucogingival line, the mesial and distal papillary midline and
           the alveolar crest. Thus, any.alterations in volume between the digitized superimposed
           replicas could be recorded. (Akcali et al., 2015)

           • Pink esthetic score. Pink esthetic score will be recorded for five variables: "mesial
           papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and
           root convexity/soft tissue color and texture at the facial aspect of the implant site".
           A score of 2, 1, or 0 will be assigned to all five PES parameters.

           The two papillary scores (mesial and distal) will be assessed for the complete presence
           (score 2), incomplete presence (score 1) or absence (score0) of papillary tissue. The
           curvature of the facial soft tissue line, also defined as the line of emergence of the
           implant restoration from the soft tissues, will be evaluated as being identical (score 2
           ), slightly different (score 1), or markedly different (score 0) compared to the natural
           control tooth and thus, provided a natural symmetrical or disharmonious appearance and
           in comparison to the contralateral tooth in terms of an identical vertical level (score
           2), a slight (<1 mm) discrepancy (score 1), or a major (>1 mm) discrepancy (score 0).
           Finally, the combined three additional specific soft tissue parameters as one variable:
           the presence, partial presence, or absence of a convex profile (in analogy to a root
           eminence) on the facial aspect, as-well-as-the-related-mucosal-color-and-surface
           texture. To achieve a score of 2 for this-combination-variable,
           all-three-parameters-were more-or-less-identical-compared-to-the-control-tooth. A value
           of 1 will be given if two criteria are fulfilled, whereas a score of 0 will be given if
           none or only one parameter matches the control site. (Tettamanti et al, 2014)

             -  Visual analogue scale to measure postoperative pain.
                Pain.score.reported.by.the.patient. directly.through.Visual.Analogue.Scale.score
                (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain) VAS
                will be recorded after 2 weeks (Yıldırım et al., 2017)

             -  The OHIP (OHIP-14 questionnaire) Will be used to assess limitation of function ,
                pain , discomfort, social , psychological ,physical disability and general
                satisfaction. The OHIP-14 utilizes a scale with five categories (1 = never, 2 =
                hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often).A lower score
                in any of the five categories indicates higher satisfaction. (Al-zubeidi et al,
                2011)

             -  Soft tissue thickness will be measured at baseline and 9 months postoperatively
                using.an.anesthetic.needle.with.a.rubber.stopper to pierce the gingiva horizontally
                and perpendicular to the long axis of the tooth till bone contact 2mm coronal to
                the MGJ and in the mid distance mesiodistally

             -  The part of the instrument penetrating into soft tissue will be measured in mm.
                (Cairo et al 2017)

        2. Radiographic Examination:

             -  Cone Beam Computed Tomography (CBCT) will be taken at baseline before implant
                placement and 9 months later to measure soft tissue thickness.

      Statistical analysis:

      The collected data will be revised, coded, tabulated and introduced to a PC using Statistical
      package for Social Science (SPSS 15.0 for windows; SPSS Inc, Chicago, IL, 2001). Data will be
      presented and suitable analysis will be done according to the type of data obtained for each
      parameter.
    

Intervention name(s): volume stable collagen matrix placement; connective tissue grafting
Intervention type(s): Biological; Procedure
Intervention description(s): volume stable collagen matrix placement to augment the buccal defect.in class I siebert at the same time of implant placement; connective tissue placement to augment the buccal defect.in class I siebert at the same time of implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: siebert; dental implant; volume stable collagen matrix; connective tissue