Peri-Implant Papilla DeficiencymLPPF-dGGNCT07204353
Modified Labial Pedicle Papilla Flap (mLPPF) With or Without De-epithelialized Gingival Graft (dGG) for Peri-implant Papilla Reconstruction
A study testing Modified Labial Pedicle Papilla Flap (mLPPF) and Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG) in people with Peri-Implant Papilla Deficiency, run by Cuneyt Asim Aral at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aims to evaluate the effectiveness of two surgical techniques for peri-implant papilla reconstruction in single-tooth implants in the maxillary anterior and premolar regions. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Papilla Deficiency
- What is being tested?
- Modified Labial Pedicle Papilla Flap (mLPPF) and Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 23 Jun 2025
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were eligible for inclusion if they:
- Were between 22 and 45 years of age
- Voluntarily agreed to participate in the study
- Had good periodontal health defined as full-mouth bleeding on probing scores, with <10%
- Had a single missing tooth in the maxillary anterior or premolar region with both neighbouring teeth present
- Had peri-implant papilla loss defined as JEMT score <3
Who cannot join
- Participants were excluded if they:
- Were smokers
- Had any systemic condition that could potentially influence study outcomes or implant success, such as diabetes mellitus, osteoporosis, or a history of radiotherapy
- Were undergoing pharmacological treatment that could affect the results, including the use of bisphosphonates, immunosuppressive agents, or regular analgesic medications
- Had clinical signs of peri-implant mucositis or peri-implantitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, 44210
About this study
Official title: A Novel Surgical Procedure for Peri-implant Papilla Reconstruction in the Aesthetic Region: Modified Labial Pedicle Papilla Flap Technique With De-epithelialized Gingival Graft
This randomized controlled clinical trial aims to evaluate the effectiveness of two surgical techniques for peri-implant papilla reconstruction in single-tooth implants in the maxillary anterior and premolar regions. A total of 80 cases with papilla deficiency were allocated into three groups: papilla-preserving incisions only (Control), modified labial pedicle papilla flap (mLPPF), and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Clinical outcomes including papilla fill (Jemt scores), papilla height, and crestal mucosa thickness were assessed at baseline, immediately after surgery, two weeks postoperatively, and six months after final restoration. The primary goal is to determine whether combining connective tissue grafting with flap surgery provides superior and more stable papilla reconstruction compared with papilla preserving flap-only approaches.
Read the detailed description
Peri-implant papilla deficiency remains one of the most challenging aspects of achieving esthetic success in implant dentistry, particularly in the anterior maxilla where soft tissue harmony plays a pivotal role. Despite the development of several surgical and prosthetic techniques, no universally accepted gold standard procedure or biomaterial has been established for papilla reconstruction.
This randomized controlled clinical trial was designed to investigate the clinical outcomes of two surgical approaches for peri-implant papilla reconstruction: the modified labial pedicle papilla flap (mLPPF) performed alone, and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Patients presenting with single-tooth missing sites in the maxillary anterior or premolar regions, associated with papilla loss, were recruited. A total of 80 cases were allocated to three groups:
Control group - papilla-preserving incisions only,
mLPPF group - surgical papilla reconstruction with a modified pedicle flap,
mLPPF+dGG group - flap reconstruction combined with a connective tissue graft harvested and de-epithelialized from the palate.
Clinical outcomes included Jemt papilla index scores, papilla height (measured using standardized intraoral photography and STL files), and crestal mucosa thickness. Measurements were obtained at baseline (T0), immediately after surgery (T1), two weeks postoperatively (T2), and six months after prosthetic restoration (T3).
The primary hypothesis was that combining flap techniques with dGG would result in superior papilla fill and long-term tissue stability compared with flap-only or incision-only techniques. Statistical analyses confirmed that the mLPPF+dGG group demonstrated significantly higher Jemt scores, papilla height, and crestal mucosa thickness from the early postoperative period through the six-month follow-up. Moreover, strong positive correlations were identified between papilla height and crestal mucosa thickness, supporting the biological interplay between vertical mucosal thickness and papillary stability.
The trial provides randomized controlled evidence that the use of de-epithelialized gingival grafts in combination with pedicle flap surgery is a predictable and effective method for peri-implant papilla reconstruction, with potential implications for clinical practice in esthetically demanding cases.
- Conditions
- Peri-Implant Papilla Deficiency
- Being tested
- Papilla-preserving incision (Control), Modified Labial Pedicle Papilla Flap (mLPPF), Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG)
- Keywords
- Peri-implant papilla reconstruction, Modified labial pedicle papilla flap (mLPPF), De-epithelialized gingival graft (dGG), Crestal mucosa thickness, Jemt papilla index, Dental implant esthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papilla-preserving incision (Control)Procedure or surgery
Standard papilla-preserving incision without additional flap modification or connective tissue grafting. This group serves as the control, receiving only routine surgical access for implant site management.
Modified Labial Pedicle Papilla Flap (mLPPF)Procedure or surgery
Surgical reconstruction of the peri-implant papilla using the modified labial pedicle papilla flap technique. The flap is mobilized and sutured without adjunctive grafting procedures.
Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG)Procedure or surgery
Surgical reconstruction of the peri-implant papilla combining the modified labial pedicle papilla flap with placement of a de-epithelialized gingival graft (dGG) at the papillary region to enhance soft tissue volume and stability.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Papilla-preserving incisions performed during implant uncovering, without additional flap modification or grafting. Receives: Procedure: Papilla-preserving incision (Control) |
| mLPPF group | Experimental | A modified labial pedicle papilla flap is advanced and sutured to reconstruct the peri-implant papilla, without connective tissue grafting. Receives: Procedure: Modified Labial Pedicle Papilla Flap (mLPPF) |
| mLPPF+dGG group | Experimental | A modified labial pedicle papilla flap is combined with placement of a de-epithelialized gingival graft harvested from the palate, sutured into the papillary region to enhance papilla reconstruction and increase mucosal thickness. Receives: Procedure: Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Papilla Height
Papilla height will be measured as the perpendicular distance from the papilla tip to a line connecting the zenith points of the two adjacent teeth, using standardized intraoral photographs and STL-based digital analysis.
Measured: Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Secondary outcomes (3)
Change in Jemt Scores
Jemt scores will be assessed based on the degree of papilla fill, ranging from 0 (no papilla) to 4 (hypertrophic papilla).
Measured: Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Change in Crestal Mucosa Thickness
Crestal mucosa thickness will be measured at the mid-buccal aspect using a standardized endodontic reamer with silicone stopper under local anesthesia. Measurements will be confirmed through STL-based analysis.
Measured: Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Correlation Between Papilla Height and Crestal Mucosa Thickness
The relationship between papilla height and crestal mucosa thickness will be analyzed to determine the impact of vertical soft tissue thickness on papilla stability.
Measured: Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Feb 2021
- Primary completion25 May 2024
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peri-Implant Papilla DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuneyt Asim Aral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cuneyt Asim Aral, Inonu University
- Investigators
- Cüneyt A Aral, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204353
- Sponsor's protocol ID
- IUCREC.2024.161
- Acronym
- mLPPF-dGG
- Status last verified
- Aug 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choquet V, Hermans M, Adriaenssens P, Daelemans P, Tarnow DP, Malevez C. Clinical and radiographic evaluation of the papilla level adjacent to single-tooth dental implants. A retrospective study in the maxillary anterior region. J Periodontol. 2001 Oct;72(10):1364-71. doi: 10.1902/jop.2001.72.10.1364.
PubMed 11699478Gholami GA, Hariri S, Amid R, Roghanizadeh L, Kadkhodazadeh M, Mehdizadeh A, Youssefi N. Average and Maximum Papilla Heights around Dental Implants in the Anterior Maxillary Region: A Retrospective Clinical Study. Int J Dent. 2022 Feb 11;2022:4235946. doi: 10.1155/2022/4235946. eCollection 2022.
PubMed 35186085Tarnow DP, Magner AW, Fletcher P. The effect of the distance from the contact point to the crest of bone on the presence or absence of the interproximal dental papilla. J Periodontol. 1992 Dec;63(12):995-6. doi: 10.1902/jop.1992.63.12.995.
PubMed 1474471Botticelli D, Agabiti I, Yamada R, Maniwa N, Apaza Alccayhuaman KA, Nakajima Y. Identifying Key Factors in Papilla Growth Around Implants: Focus on Intraoral Negative Pressure. Dent J (Basel). 2025 Mar 13;13(3):124. doi: 10.3390/dj13030124.
PubMed 40136752Beagle JR. Surgical reconstruction of the interdental papilla: case report. Int J Periodontics Restorative Dent. 1992;12(2):145-51.
PubMed 1521996
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Surgical Procedure for Peri-implant Papilla Reconstruction in the Aesthetic Region: Modified Labial Pedicle Papilla Flap Technique With De-epithelialized Gingival Graft
- ClinicalTrials.gov ID
- NCT07204353
- Acronym / sponsor ID
- mLPPF-dGG / IUCREC.2024.161
- Conditions
- Peri-Implant Papilla Deficiency
- Keywords
- Peri-implant papilla reconstruction, Modified labial pedicle papilla flap (mLPPF), De-epithelialized gingival graft (dGG), Crestal mucosa thickness, Jemt papilla index, Dental implant esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cuneyt Asim AralUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 2 Oct 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.
This randomized controlled clinical trial aims to evaluate the effectiveness of two surgical techniques for peri-implant papilla reconstruction in single-tooth implants in the maxillary anterior and premolar regions. A total of 80 cases with papilla deficiency were allocated into three groups: papilla-preserving incisions only (Control), modified labial pedicle papilla flap (mLPPF), and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Clinical outcomes including papilla fill (Jemt scores), papilla height, and crestal mucosa thickness were assessed at baseline, immediately after surgery, two weeks postoperatively, and six months after final restoration. The primary goal is to determine whether combining connective tissue grafting with flap surgery provides superior and more stable papilla reconstruction compared with papilla preserving flap-only approaches.
Detailed description
Peri-implant papilla deficiency remains one of the most challenging aspects of achieving esthetic success in implant dentistry, particularly in the anterior maxilla where soft tissue harmony plays a pivotal role. Despite the development of several surgical and prosthetic techniques, no universally accepted gold standard procedure or biomaterial has been established for papilla reconstruction.
This randomized controlled clinical trial was designed to investigate the clinical outcomes of two surgical approaches for peri-implant papilla reconstruction: the modified labial pedicle papilla flap (mLPPF) performed alone, and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Patients presenting with single-tooth missing sites in the maxillary anterior or premolar regions, associated with papilla loss, were recruited. A total of 80 cases were allocated to three groups:
Control group - papilla-preserving incisions only,
mLPPF group - surgical papilla reconstruction with a modified pedicle flap,
mLPPF+dGG group - flap reconstruction combined with a connective tissue graft harvested and de-epithelialized from the palate.
Clinical outcomes included Jemt papilla index scores, papilla height (measured using standardized intraoral photography and STL files), and crestal mucosa thickness. Measurements were obtained at baseline (T0), immediately after surgery (T1), two weeks postoperatively (T2), and six months after prosthetic restoration (T3).
The primary hypothesis was that combining flap techniques with dGG would result in superior papilla fill and long-term tissue stability compared with flap-only or incision-only techniques. Statistical analyses confirmed that the mLPPF+dGG group demonstrated significantly higher Jemt scores, papilla height, and crestal mucosa thickness from the early postoperative period through the six-month follow-up. Moreover, strong positive correlations were identified between papilla height and crestal mucosa thickness, supporting the biological interplay between vertical mucosal thickness and papillary stability.
The trial provides randomized controlled evidence that the use of de-epithelialized gingival grafts in combination with pedicle flap surgery is a predictable and effective method for peri-implant papilla reconstruction, with potential implications for clinical practice in esthetically demanding cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Papilla-preserving incision (Control)Papilla-preserving incisions performed during implant uncovering, without additional flap modification or grafting. |
| mLPPF group | Experimental | Procedure: Modified Labial Pedicle Papilla Flap (mLPPF)A modified labial pedicle papilla flap is advanced and sutured to reconstruct the peri-implant papilla, without connective tissue grafting. |
| mLPPF+dGG group | Experimental | Procedure: Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG)A modified labial pedicle papilla flap is combined with placement of a de-epithelialized gingival graft harvested from the palate, sutured into the papillary region to enhance papilla reconstruction and increase mucosal thickness. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants were eligible for inclusion if they:
Key exclusion criteria (5 listed)
- Participants were excluded if they:
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 |
|---|---|---|
| Papilla-preserving incision (Control)Standard papilla-preserving incision without additional flap modification or connective tissue grafting. This group serves as the control, receiving only routine surgical access for implant site management. | Procedure or surgery | Control group |
| Modified Labial Pedicle Papilla Flap (mLPPF)Surgical reconstruction of the peri-implant papilla using the modified labial pedicle papilla flap technique. The flap is mobilized and sutured without adjunctive grafting procedures. | Procedure or surgery | mLPPF group |
| Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG)Surgical reconstruction of the peri-implant papilla combining the modified labial pedicle papilla flap with placement of a de-epithelialized gingival graft (dGG) at the papillary region to enhance soft tissue volume and stability. | Procedure or surgery | mLPPF+dGG group |
Primary outcome
Change in Papilla Height
Time frame: Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Papilla height will be measured as the perpendicular distance from the papilla tip to a line connecting the zenith points of the two adjacent teeth, using standardized intraoral photographs and STL-based digital analysis.
3 secondary outcomes
Change in Jemt Scores
Time frame: Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Change in Crestal Mucosa Thickness
Time frame: Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
Correlation Between Papilla Height and Crestal Mucosa Thickness
Time frame: Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).
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 2 Oct 2025.
- Background: PubMed 11699478Choquet V, Hermans M, Adriaenssens P, Daelemans P, Tarnow DP, Malevez C. Clinical and radiographic evaluation of the papilla level adjacent to single-tooth dental implants. A retrospective study in the maxillary anterior region. J Periodontol. 2001 Oct;72(10):1364-71. doi: 10.1902/jop.2001.72.10.1364.
- Background: PubMed 35186085Gholami GA, Hariri S, Amid R, Roghanizadeh L, Kadkhodazadeh M, Mehdizadeh A, Youssefi N. Average and Maximum Papilla Heights around Dental Implants in the Anterior Maxillary Region: A Retrospective Clinical Study. Int J Dent. 2022 Feb 11;2022:4235946. doi: 10.1155/2022/4235946. eCollection 2022.
- Background: PubMed 1474471Tarnow DP, Magner AW, Fletcher P. The effect of the distance from the contact point to the crest of bone on the presence or absence of the interproximal dental papilla. J Periodontol. 1992 Dec;63(12):995-6. doi: 10.1902/jop.1992.63.12.995.
- Background: PubMed 40136752Botticelli D, Agabiti I, Yamada R, Maniwa N, Apaza Alccayhuaman KA, Nakajima Y. Identifying Key Factors in Papilla Growth Around Implants: Focus on Intraoral Negative Pressure. Dent J (Basel). 2025 Mar 13;13(3):124. doi: 10.3390/dj13030124.
- Background: PubMed 1521996Beagle JR. Surgical reconstruction of the interdental papilla: case report. Int J Periodontics Restorative Dent. 1992;12(2):145-51.
- Individual participant dataSharing planned: Undecided
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.
Cüneyt A Aral study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Labial Pedicle Papilla Flap (mLPPF) and Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG) in people with Peri-Implant Papilla Deficiency, run by Cuneyt Asim Aral at 1 site in Turkey (Türkiye).
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 6 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 2 Oct 2025. 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 Turkey (Türkiye). 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?
Change in Papilla Height (time frame: Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07204353, which also lists 5 linked publications.
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 2 Oct 2025.