Papilla ReconstructionNCT06813846
Assessment of Pink Esthetic Score After Using Two Papilla Reconstruction Exposure Techniques Versus Mid-Crestal Sulcular Incision in Second Stage Implant Surgery: A Randomized Controlled Clinical Trail
A study testing Mid-Crestal Sulcular Incision, Split-Finger Procedure and "I" shaped incision in people with Papilla Reconstruction, run by British University In Egypt at 1 site in Egypt.
Trial summary
The purpose of this randomized clinical trial is to assess the pink esthetic score with three different techniques in second-stage implant surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papilla Reconstruction
- What is being tested?
- Mid-Crestal Sulcular Incision, Split-Finger Procedure and "I" shaped incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2025to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who already received implants in the anterior and premolar region
- All implants were placed 4 months prior to uncovering in the mandible and 6 months prior to uncovering in the maxilla.
- Patients with good oral hygiene
- Medically free patients
- Adequate keratinized tissue
Who cannot join
- Acute infection
- Occlusal trauma
- Smokers
- Pregnancy and lactation
- Severe gag reflex
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized clinical trial is to assess the pink esthetic score with three different techniques in second-stage implant surgery.
- Conditions
- Papilla Reconstruction
- Being tested
- Mid-Crestal Sulcular Incision, Split-Finger Procedure, "I" shaped incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-Crestal Sulcular IncisionProcedure or surgery
A long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw.
Split-Finger ProcedureProcedure or surgery
The surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures.
"I" shaped incisionProcedure or surgery
A Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture.
| Study group | Role | What they receive |
|---|---|---|
| "I" shaped incision | Experimental | A Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture. Receives: Procedure: "I" shaped incision |
| Split-Finger Procedure | Experimental | The surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures. Receives: Procedure: Split-Finger Procedure |
| Mid-Crestal Sulcular Incision | Active comparator | A long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw. Receives: Procedure: Mid-Crestal Sulcular Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Months
Secondary outcomes (4)
Healing Index
The healing index included five clinical outcome parameters: tissue color (percent of red vs pink gingiva), presence of bleeding on palpation, presence of granulation tissue, incision margin (epithelization and connective tissue exposure), and presence of suppuration. The final score ranged from 0 (poor healing) to 5 (excellent healing).
Measured: 1 Month
Volumetric Changes
To assess the volumetric differences between the baseline, 3, 6 and 9 months postoperatively. 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, alterations in volume between the digitized superimposed replicas could be recorded.
Measured: baseline, 3, 6 and 9 months
Visual analogue scale
Pain score is reported by the patient directly through The Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain)
Measured: 2 Weeks
The Oral health impact profile (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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start12 Feb 2025
- Primary completion22 Apr 2025
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilla ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Rajab, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813846
- Sponsor's protocol ID
- 23-035
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pink Esthetic Score After Using Two Papilla Reconstruction Exposure Techniques Versus Mid-Crestal Sulcular Incision in Second Stage Implant Surgery: A Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT06813846
- Acronym / sponsor ID
- 23-035
- Conditions
- Papilla Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized clinical trial is to assess the pink esthetic score with three different techniques in second-stage implant surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "I" shaped incision | Experimental | Procedure: "I" shaped incisionA Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture. |
| Split-Finger Procedure | Experimental | Procedure: Split-Finger ProcedureThe surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures. |
| Mid-Crestal Sulcular Incision | Active comparator | Procedure: Mid-Crestal Sulcular IncisionA long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who already received implants in the anterior and premolar region
- All implants were placed 4 months prior to uncovering in the mandible and 6 months prior to uncovering in the maxilla.
- Patients with good oral hygiene
- Medically free patients
- Adequate keratinized tissue
Key exclusion criteria (5 listed)
- Acute infection
- Occlusal trauma
- Smokers
- Pregnancy and lactation
- Severe gag reflex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mid-Crestal Sulcular IncisionA long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw. | Procedure or surgery | Mid-Crestal Sulcular Incision |
| Split-Finger ProcedureThe surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures. | Procedure or surgery | Split-Finger Procedure |
| "I" shaped incisionA Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture. | Procedure or surgery | "I" shaped incision |
Primary outcome
Pink Esthetic Score
Time frame: 6 Months
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
4 secondary outcomes
Healing Index
Time frame: 1 Month
Volumetric Changes
Time frame: baseline, 3, 6 and 9 months
Visual analogue scale
Time frame: 2 Weeks
The Oral health impact profile (OHIP-14 questionnaire)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mid-Crestal Sulcular Incision, Split-Finger Procedure and "I" shaped incision in people with Papilla Reconstruction, run by British University In Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.